Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (EASE Clinical Trial)
Phase: NA
Conditions: Menorrhagia, Heavy Menstrual Bleeding, Heavy Uterine Bleeding
Sponsor: MicroCube, LLC

MicroCube, LLC. 
 
Protocol # TD18036 
Version: 5.0 / 14Dec2021 
 
 
 
 
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COVER PAGE 
 
 
Minitouch Endometrial Ablation System Treatment for Menorrhagia:  
An Evaluation of Safety & Effectiveness 
(EASE Clinical Trial) 
 
 
Protocol Version Number: 5.0 
 
 
Title 
Minitouch Endometrial Ablation System Treatment for Menorrhagia: 
An Evaluation of Safety & Effectiveness  
Short Title 
EASE Clinical Trial 
IDE No. 
G180282 
ClinicalTrials.gov 
Identifier 
NCT04267562 
Protocol No. & 
Revision 
TD18036 v5.0 
Version Date 
14Dec2021 
 
 
This document contains confidential and proprietary information provided by the Sponsor.  This information is 
intended for review and use by the Investigator, his/her staff, the Institutional Review Board (IRB) or Research Ethics 
Committee (REC), FDA and other regulatory agencies and is not to be disclosed to others without written permission 
from the Sponsor.  Please note that throughout this document, references to FDA are not inclusive and approval by 
the appropriate institutional and regulatory agencies are required. 
 
 

MicroCube, LLC. 
 
Protocol # TD18036 
Version: 5.0 / 14Dec2021 
 
 
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Minitouch Endometrial Ablation System Treatment for Menorrhagia:  
An Evaluation of Safety & Effectiveness 
(EASE Clinical Trial) 
 
 
Protocol Version Number: 5.0 
 
 
National  
Principal Investigator: 
 
 
nter 
  
 
 
National  
Co-Principal Investigator: 
 
 
Site Principal Investigators 
and Investigation Sites: 
Refer to https://ClinicalTrials.gov (NCT04267562) 
Details to be provided in the Clinical Investigation Report 
Sponsor: 
MicroCube, LLC 
47853 Warm Springs Blvd. 
Fremont, CA  94539 
 
 
 
This document contains confidential and proprietary information provided by the Sponsor.  This information is 
intended for review and use by the Investigator, his/her staff, the Institutional Review Board (IRB) or Research Ethics 
Committee (REC), FDA and other regulatory agencies and is not to be disclosed to others without written permission 
from the Sponsor.  Please note that throughout this document, references to FDA are not inclusive and approval by 
the appropriate institutional and regulatory agencies are required. 
 
 
 

MicroCube, LLC. 
Protocol # TD18036 
Version: 5.0 / 14Dec2021 
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VERSION HISTORY 
Version 
Version Date 
Summary of Significant Changes 
(as appropriate, refer to Summary of Changes Table for a detailed listing) 
1.0 
16Apr2019 
 
 FDA 
 
 
2.0 
19Nov2019 
 
a 
 
o 
 
s
 
 
erim analysis
 
 
3.0 
01May2020 
 
 
 
o
s
o
s
x 
 
o
he National Co-PI for the EASE
o
y
 
4.0 
31Aug2020 
 
 
 
 
 
 
 
5.0 
14Dec2021 
 
 
o
 
o
l
 
e
 
: 
o
nd 12-months
o
larity and flow
 
: 
o
.
 
o
 
9

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1 
SPONSOR APPROVAL SIGNATURE PAGE 
Compliance Statement 
This protocol is for the conduct of a clinical study that complies with requirements of Protection of Human 
Patients (Informed Consent) (21 CFR Part 50), Financial Disclosure by Clinical Investigators (21 CFR Part 
54), Institutional Review Boards (21 CFR Part 56), Investigational Device Exemptions (21 CFR Part 812), the 
Declaration of Helsinki, the privacy requirements of the Health Information Portability and Accountability 
Act (HIPAA) (45 CFR Part 160 and Subparts A and E of Part 164), and Clinical Trials Registration and Results 
Information Submission (42 CFR Part 11), ICH Good Clinical Practice and ISO 14155 Clinical investigation of 
medical devices for human subjects — Good clinical practice.  The most stringent requirements, 
guidelines or regulations must always be followed.  The conduct of the trial will be approved by the 
appropriate Institutional Review Board (IRB)/Research Ethics Committee (REC) of the respective 
investigational site and by the applicable regulatory authorities (e.g., FDA).   
 
 
 
 
 
 


	

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2 
INVESTIGATOR SIGNATURE PAGE 
 
x 
I have read and understood the contents of this protocol: Minitouch Endometrial Ablation System 
Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (EASE Clinical Trial). 
x 
I agree that it contains all necessary details for carrying out the study as described and I will conduct 
this study as outlined herein, including all requirements regarding confidentiality.  
x 
I will make a reasonable effort to complete the study within the time discussed.  
x 
I will provide copies of the protocol and access to all information furnished by the Sponsor to study 
personnel under my supervision. I will discuss this material with them to ensure that they are fully 
informed about the investigational device and the study.  
x 
I understand that the study may be terminated, or enrollment suspended, at any time by the 
Sponsor, with or without cause, or by me if it becomes necessary to protect the best interests of the 
study subjects.  
x 
I agree to conduct this study in full accordance with this protocol, all applicable regulations, including 
the Protection of Human Patients (Informed Consent) (21 CFR Part 50), Financial Disclosure by Clinical 
Investigators (21 CFR Part 54), Institutional Review Boards (21 CFR Part 56), Investigational Device 
Exemptions (21 CFR Part 812), the Declaration of Helsinki, the privacy requirements of the Health 
Information Portability and Accountability Act (HIPAA) (45 CFR Part 160 and Subparts A and E of Part 
164), ICH Good Clinical Practice and ISO 14155.  I will follow the most stringent requirements, 
guidelines and regulations. 
x 
I understand and agree to abide by the obligations set forth in the Investigator Agreement. 
x 
I agree to participate in the Sponsor’s training program prior to site initiation and I will ensure that 
the investigational device is only used by authorized users. 
The Site Principal Investigator may delegate one or more of the above functions to an associate or Sub-
Investigator. However, the Site Principal Investigator retains overall responsibility for proper conduct of 
the study, including obtaining and documenting patient informed consent, compliance with the protocol 
and the collection of all required data. 
 
 
 
Site Principal Investigator’s Printed Name  
 
 
Site Principal Investigator’s Signature  
 
Date 
Site Name 
 
 
 

MicroCube, LLC. 
 
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3 
SPONSOR CONTACT 
 
 
Sponsor Contact: 
 
 
 
Corporate Address: 
47853 Warm Springs Blvd.  
Fremont, CA  94539 
United States 
Email:  
 
  
 
Text: 
 
 
 
 
 
Consult the EASE Clinical Trial Contact Information List for inquiries and further information about 
the study or for reporting serious adverse events and other emergencies. 
 
 
 
 
 

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Table of Contents 
1 
SPONSOR APPROVAL SIGNATURE PAGE ............................................................... 3 
2 
INVESTIGATOR SIGNATURE PAGE ......................................................................... 4 
3 
SPONSOR CONTACT ............................................................................................. 5 
4 
ABBREVIATIONS & TERMS .................................................................................. 12 
5 
PROTOCOL SYNOPSIS ......................................................................................... 14 
6 
BACKGROUND.................................................................................................... 19 
6.1 
Summary of Pre-Clinical and Clinical Testing (Prior Clinical Experience) ........................ 20 
7 
STUDY OBJECTIVE .............................................................................................. 21 
7.1 
Device and Study Rationale ............................................................................................. 21 
7.2 
Study Objectives .............................................................................................................. 21 
7.2.1 
Primary Objective ..................................................................................................... 21 
7.2.2 
Secondary Objective ................................................................................................ 21 
8 
DEVICE DESCRIPTION ......................................................................................... 21 
8.1 
System Overview ............................................................................................................. 21 
8.2 
Principle of Operation ..................................................................................................... 22 
8.3 
Proposed Indications for Use (IFU) .................................................................................. 23 
8.4 
Device Instructions .......................................................................................................... 23 
9 
STUDY ENDPOINTS ............................................................................................. 23 
9.1 
Primary Effectiveness Endpoint....................................................................................... 23 
9.2 
Primary Safety Endpoint .................................................................................................. 24 
9.3 
Secondary Outcome Measures ....................................................................................... 24 
10 
STUDY DESIGN ................................................................................................ 25 
11 
PATIENT ENROLLMENT AND SELECTION .......................................................... 27 
11.1 
Study Population .......................................................................................................... 27 
11.2 
Prescreening ................................................................................................................ 27 
11.3 
Patient Selection Criteria ............................................................................................. 27 
11.3.1 
Inclusion Criteria ...................................................................................................... 27 
11.3.2 
Exclusion Criteria ...................................................................................................... 28 
11.4 
Rescreening.................................................................................................................. 29 
11.5 
Informed Consent ........................................................................................................ 29 

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11.6 
Patient Privacy ............................................................................................................. 29 
11.7 
Strategies for Recruitment and Retention ................................................................... 30 
11.7.1 
Special Population .................................................................................................... 30 
11.7.2 
Control of Bias Section ............................................................................................. 30 
11.8 
Patient Discontinuation and Replacement .................................................................. 30 
11.8.1 
Reasons for Termination .......................................................................................... 30 
11.9 
Point of Enrollment ...................................................................................................... 31 
11.10 
Completion of the Clinical Investigation ...................................................................... 32 
12 
STUDY VISIT INSTRUCTIONS ............................................................................ 32 
12.1 
Schedule of Events ....................................................................................................... 32 
12.2 
Validity Windows for Baseline Testing ........................................................................ 32 
12.3 
Screening Visits ............................................................................................................ 33 
12.3.1 
Suggested Order of Events: ...................................................................................... 33 
12.3.2 
Pictorial Blood Loss Assessment Chart ..................................................................... 33 
12.3.3 
Screen Failures ......................................................................................................... 34 
12.4 
Procedure (Day 0) – Enrollment / Discharge ............................................................... 34 
12.4.1 
Procedure Visit Strategy ........................................................................................... 34 
12.4.2 
Suggested Order of Events ....................................................................................... 34 
12.5 
Standard of Care Contact After 24 hours .................................................................... 34 
12.6 
Week 2 Visit (± 7 days) ................................................................................................. 35 
12.7 
Follow-up Visits Conducted 3 and 6 Months (± 2 weeks) After Treatment ................ 35 
12.8 
Endpoint Visit at Month 12 (± 4 weeks) ...................................................................... 35 
12.9 
Durability Visits Conducted 24 and 36 Months (± 8 weeks) After Treatment ............. 35 
12.10 
Pre-Endpoint Termination Visit ................................................................................... 35 
12.11 
Unscheduled Visits ....................................................................................................... 35 
13 
STUDY PROCEDURES / EVALUATIONS .............................................................. 36 
13.1 
Prescreening ................................................................................................................ 36 
13.2 
Demographic Data and Medical History ...................................................................... 36 
13.3 
Physical Examination / Gynecological Exam ................................................................ 37 
13.4 
Endometrial Biopsy, Ultrasound, Sonohysterography, Hysteroscopy ......................... 37 
13.5 
Vital Signs ..................................................................................................................... 37 
13.6 
Concomitant Medications ........................................................................................... 37 

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13.6.1 
Screening and Follow-up .......................................................................................... 37 
13.6.2 
Contraception .......................................................................................................... 37 
13.7 
Adverse Events............................................................................................................. 38 
13.8 
Complete Blood Count (CBC) and Serum FSH .............................................................. 38 
13.9 
Urine Pregnancy Test ................................................................................................... 38 
13.10 
Menorrhagia Impact Questionnaire (MIQ) .................................................................. 38 
13.11 
PBLAC Diaries ............................................................................................................... 38 
13.11.1 
PBLAC Training ...................................................................................................... 38 
13.11.2 
Administering PBLAC Diaries ................................................................................ 39 
13.11.3 
Sanitary Products .................................................................................................. 39 
13.12 
Numerical Rating Scale (NRS) ...................................................................................... 39 
13.12.1 
NRS for Dysmenorrhea-related Pain .................................................................... 39 
13.12.2 
NRS for Procedure-related Pelvic Pain ................................................................. 39 
13.13 
Patient Global Evaluation ............................................................................................ 39 
13.14 
Investigator Global Evaluation ..................................................................................... 40 
13.15 
Device-related Issues or Device Deficiency/Malfunction ............................................ 40 
13.16 
Minitouch Procedure ................................................................................................... 40 
13.16.1 
Investigational Devices ......................................................................................... 40 
13.16.2 
Support ................................................................................................................. 40 
13.16.3 
Procedure Medications ........................................................................................ 40 
14 
ADVERSE EVENT REPORTING ........................................................................... 41 
14.1 
Adverse Event Definitions ............................................................................................ 41 
14.1.1 
Adverse Event (AE): .................................................................................................. 41 
14.1.2 
Serious Adverse Events (SAEs) ................................................................................. 41 
14.1.3 
Anticipated Adverse Device Effects Associated with Endometrial Ablation ............ 41 
14.1.4 
Unanticipated Adverse Device Effects (UADEs) ....................................................... 43 
14.1.5 
Not Adverse Events .................................................................................................. 43 
14.1.6 
Adverse Events that do not require reporting to Sponsor ....................................... 43 
14.2 
Recording Adverse Events ........................................................................................... 44 
14.2.1 
Adverse Event Evaluation and Categorization ......................................................... 44 
14.2.2 
Intensity (Severity) ................................................................................................... 44 
14.2.3 
Other Adverse Events ............................................................................................... 44 

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14.2.4 
Determination of the Relationship (Causality) ......................................................... 44 
14.3 
Reporting Requirements for SAEs or UADEs ............................................................... 45 
14.4 
Medical Treatment for AEs, SAEs and UADEs .............................................................. 45 
15 
CLINICAL EVENTS COMMITTEE ........................................................................ 45 
16 
RISKS AND BENEFITS ....................................................................................... 45 
16.1 
Potential Risks .............................................................................................................. 45 
16.1.1 
Procedure Risks ........................................................................................................ 45 
16.2 
Risk Management Procedures ..................................................................................... 46 
16.3 
Potential Benefits ........................................................................................................ 46 
17 
STATISTICAL METHODS AND CONSIDERATIONS ............................................... 46 
17.1 
Analysis Cohorts ........................................................................................................... 46 
17.1.1 
Intent-to-Treat (ITT) Cohort ..................................................................................... 46 
17.1.2 
Per Protocol (PP) Cohort .......................................................................................... 47 
17.2 
Analysis of Primary Efficacy Endpoint at 12-month .................................................... 47 
17.2.1 
Study Power ............................................................................................................. 48 
17.3 
Predictive Analysis 12, 24, and 36-month Efficacy Outcome ...................................... 48 
17.4 
Analysis of Primary Safety Endpoint at 12-month ....................................................... 48 
17.5 
Analysis of All Safety Outcome .................................................................................... 48 
17.6 
Analysis of Secondary Endpoints ................................................................................. 48 
17.7 
Subgroup Analyses ....................................................................................................... 48 
17.8 
Exploratory Analyses.................................................................................................... 49 
18 
STUDY RECORD MANAGEMENT ....................................................................... 49 
18.1 
Source Documentation ................................................................................................ 49 
18.2 
Data Collection and Electronic Case Report Form Completion ................................... 50 
18.3 
Investigational Devices ................................................................................................ 50 
18.3.1 
Labeling .................................................................................................................... 50 
18.3.2 
Ordering, Receiving and Storing Investigational Device .......................................... 50 
18.3.3 
Investigational Device Accountability ...................................................................... 51 
18.3.4 
Device Disposal or Return ........................................................................................ 51 
18.4 
Data Management and Processing .............................................................................. 51 
19 
TRAINING ........................................................................................................ 51 

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19.1 
Site Training ................................................................................................................. 51 
19.2 
Device Training ............................................................................................................ 52 
20 
MONITORING .................................................................................................. 52 
20.1 
Site Monitoring Procedures ......................................................................................... 52 
20.2 
Compliance .................................................................................................................. 53 
20.2.1 
Site Compliance ........................................................................................................ 53 
20.2.2 
Protocol Deviations .................................................................................................. 53 
21 
QUALITY CONTROL AND ASSURANCE .............................................................. 54 
21.1 
Selection of Sites and Investigators ............................................................................. 54 
21.2 
Financial Disclosure ..................................................................................................... 54 
21.3 
Institutional Review Board Protocol and Informed Consent Approvals ...................... 54 
21.4 
Protocol Amendments ................................................................................................. 55 
21.5 
Confidentiality.............................................................................................................. 55 
21.6 
Study Administration ................................................................................................... 55 
21.6.1 
Pre-Study Documentation Requirements ................................................................ 55 
21.6.2 
General Investigator Responsibilities ....................................................................... 55 
21.7 
Record Retention ......................................................................................................... 56 
21.7.1 
Health Insurance Portability and Accountability Act of 1996 .................................. 56 
21.7.2 
Criteria for Suspending/Terminating a Study Center ............................................... 56 
21.8 
Publication Policy ......................................................................................................... 57 
22 
REFERENCES .................................................................................................... 58 
23 
SCHEDULE OF EVENTS ..................................................................................... 59 
Attachment A:  Sample PBLAC Diary (pictorial diagram of pads and tampons) ........... 61 
Attachment B:  SAMPLE Menorrhagia Impact Questionnaire (MIQ) ........................... 63 
Attachment C:  SAMPLE Numerical Rating Scale (NRS) for Dysmenorrhea-related Pain 
and Procedure-related Pelvic Pain ............................................................................ 64 
Attachment D:  SAMPLE Rating Scale for Patient and User (Investigator) Global 
Evaluation of Satisfaction with the Study Treatment ................................................. 65 

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Table of Tables 
Table 4-1:   List of Abbreviations & Terms..................................................................................................... 12 
Table 12-1: Validity Windows ........................................................................................................................ 32 
Table 14-1:  Anticipated Adverse Device Effects of Endometrial Ablation ................................................... 41 
Table 23-1:  Schedule of Events .................................................................................................................... 59 
 
Table of Figures 
Figure 8-1:  Minitouch Endometrial Ablation System ................................................................................... 22 
Figure 8-2: Target Tissue Diagram (Left: Mid Coronal View, Right: Mid Sagittal View) ................................ 23 
Figure 10-1: Study Execution Diagram .......................................................................................................... 26 
 
 
 

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4 
ABBREVIATIONS & TERMS 
Table 4-1:   List of Abbreviations & Terms 
AE 
Adverse Event 
BMI 
Body Mass Index 
CBC 
Complete Blood Count 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CIN  
Cervical Intraepithelial Neoplasia 
CIP 
Clinical Investigation Plan (Protocol) 
CRF/eCRF 
Case Report Form/Electronic Case Report Form 
Discharge 
Discharge (in the context of the Minitouch procedure):  the point at which the subject 
leaves the site or institution after undergoing the Minitouch procedure  
EA 
Endometrial Ablation 
EASE 
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of 
Safety & Effectiveness Clinical Trial 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
Enrolled 
Consented-enrolled:  a consented patient that does not proceed to treatment for any 
reason (such as screen failure, declines treatment or participation) is categorized as 
consented-enrolled 
 
Treated-enrolled: a qualified patient in whom the Minitouch procedure is initiated is 
categorized as treated-enrolled 
FDA 
Food and Drug Administration 
FSH 
Follicle Stimulating Hormone 
GCP 
Good Clinical Practice 
GEA 
Global Endometrial Ablation 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HMB 
Heavy Menstrual Bleeding 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for Human Use 
IFU 
Instructions for Use 
IGE 
Investigator Global Evaluation 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
IUD 
Intrauterine Device 
IV 
Intravenous  
NIH 
National Institutes of Health 
NRS 
Numerical Rating Scale 
MIQ 
Menorrhagia Impact Questionnaire 
NSAID 
Non-steroidal Anti-inflammatory Drug 
OUS 
Outside the United States 
OPC 
Objective Performance Criteria 
PBLAC 
Pictorial Blood Loss Assessment Chart 

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Table 4-1:   List of Abbreviations & Terms 
PGE 
Patient Global Evaluation 
PE 
Physical Exam 
PI 
Principal Investigator 
PN 
Part Number 
PP 
Per Protocol 
PRN 
As needed / when necessary 
QOL 
Quality of Life 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SIS 
Saline Infused Sonohysterography 
SOC 
Standard of Care 
SOP 
Standard Operating Procedure 
STD 
Sexually Transmitted Disease 
UADE 
Unanticipated Adverse Device Effect 
UK 
United Kingdom 
ISO 14155 
Clinical investigation of medical devices for human subjects — Good clinical practice 
 
 
 

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5 
PROTOCOL SYNOPSIS 
Title 
Minitouch Endometrial Ablation System Treatment for Menorrhagia: 
An Evaluation of Safety & Effectiveness  
Short Title 
EASE Clinical Trial 
IDE No. 
G180282 
ClinicalTrials.gov 
Identifier 
NCT04267562 
Protocol No. & 
Revision 
TD18036 v5.0 
Version Date 
14Dec2021 
Study Device 
Minitouch Endometrial Ablation System (“Minitouch System”) 
Proposed Indications 
for Use 
The Minitouch Endometrial Ablation System is intended for ablation of the 
endometrial lining of the uterus for the treatment of menorrhagia (heavy menstrual 
bleeding) due to benign causes in premenopausal women for whom childbearing is 
complete 
Study Design 
This is a prospective, multi-center, open-label, single-arm, clinical investigation to 
evaluate the Minitouch Endometrial Ablation System in premenopausal women with 
menorrhagia 
Study Objective 
To evaluate the safety and effectiveness of the Minitouch System 
Study Duration 
At least 37 months, including an estimated one month of pre-enrollment assessment 
and 36 months post-treatment follow up 
Planned Number of 
Sites 
Approximately 10 sites from the United States only 
Planned Enrollment 
Up to 126 premenopausal women with menorrhagia 
Primary 
Effectiveness 
Endpoint 
Percent of patients demonstrating reduction of menstrual flow as evidenced by a 
Pictorial Blood Loss Assessment Chart (PBLAC) score of <75 at the 12-month post 
procedure time point  
Study Success 
To achieve study success, 12-month success rate should exceed the 66% Objective 
Performance Criterion (OPC) developed by the FDA, outlined in correspondence of Oct 
29, 2015(1) 
Primary Safety 
Measure 
Reported rate of device and procedure-related serious adverse events at 12-months 
post-procedure as adjudicated by the CEC  

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Secondary Outcome 
Measures 
Secondary effectiveness outcome measures include the following: 
PBLAC:  at 6 and 12 months 
x 
Menstrual Status at 6 and 12 months categorized by: 
o 
Amenorrhea:  PBLAC score 0 
o 
Light Bleeding:  PBLAC score 0 < 35.0 
o 
Normal Bleeding:  PBLAC score 35.1 to 75.0 
o 
Eumenorrhea:  PBLAC score 75.1 to 99.9 
o 
Menorrhagia:  PBLAC score >100 
 
Patient Global Evaluation (PGE):  at 6, 12, 24 and 36 months 
x 
Patient satisfaction with treatment 
x 
Menstrual status 
x 
Recommend to friends 
 
Investigator Global Evaluation (IGE):  at 6, 12, 24 and 36 months 
x 
Investigator satisfaction with treatment 
x 
Menstrual status 
 
Quality of Life Measures:  at 6, 12, 24 and 36 months 
x 
Improvement of quality of life as measured by: 
o 
Menorrhagia Impact Questionnaire (MIQ)  
o 
Dysmenorrhea-related Numerical Rating Scale (NRS) pain score  
 
Procedure: 
x 
Procedure-related Numerical Rating Scale (NRS) pain score 
x 
The following parameters will also be collected: 
o 
Total procedure time  
o 
Total treatment time (total energy delivery time) 
o 
Total procedure energy in joules 
o 
Anesthesia regimen 
o 
Procedure-related pain at pre-procedure (baseline), discharge 
and 24-hours post-procedure 
o 
Need for cervical dilation  
 
Secondary safety outcome measures include the following: 
x 
Any medical surgical intervention to treat abnormal bleeding anytime 
following the ablation procedure 
x 
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and 
Unanticipated Adverse Device Effects (UADEs) at 24 and 36 months   

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Inclusion Criteria 
Qualified participants must meet all of the following inclusion criteria: 
1) Female age 30 to 50 years 
2) Excessive menstrual bleeding due to benign causes  
3) Uterine sounding depth measurement of 6.0 – 12.0 cm (external os to internal 
fundus) 
4) A minimum uterine cavity length of 4.0 cm (internal os to internal fundus) 
5) ŵŝŶŝŵƵŵW>ƐĐŽƌĞŽĨшϭϱϬĨŽƌϭmenstrual cycle (obtained during 
screening) and must also have a documented history of excessive menstrual 
bleeding prior to study enrollment   
6) Endometrial biopsy within 12 months prior to treatment procedure with no 
abnormal pathology  
7) Premenopausal at screening ĂƐĚĞƚĞƌŵŝŶĞĚďǇ&^,ŵĞĂƐƵƌĞŵĞŶƚчϰϬ/hͬ> when 
age is ш 40 years 
8) Patient agrees to use a reliable form of contraception during the study, and to 
follow these requirements:  
a. If a hormonal birth control method is used for contraception, the patient 
ŵƵƐƚŚĂǀĞďĞĞŶŽŶƐĂŝĚŵĞƚŚŽĚĨŽƌшϯŵŽŶƚŚƐƉƌŝŽƌƚŽ the onset of the 
screening menstrual cycle and agrees to remain on the same hormonal 
regimen through the initial 12-month post-treatment follow-up (pills, 
injections, patches, rings, implants) 
b. Patient also agrees to not use hormonal birth control during the first 12-
month post-treatment follow-up period if they were not using hormonal birth 
control during the 3 months prior to treatment 
9) Ability to provide written informed consent  
10) Patient is literate and clearly demonstrates understanding on how to use PBLAC 
after training 
11) Patient agrees to the following during the study: 
a. No initiation of hormonal contraception or any other medical intervention for 
bleeding  
b. Attend all follow-up exams through the 36-month follow-up timepoint 
c. 
Exclusive use of study-provided sanitary products and submission of 
completed PBLAC diaries through the 12-month post-treatment follow-up 

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Exclusion Criteria 
Qualified participants must NOT meet any of the following exclusion criteria: 
1) Pregnant, or desires to retain fertility 
2) Current or documented history of endometrial hyperplasia 
3) Active endometritis 
4) Clinically significant or suspected adenomyosis indicated by patient 
complaints, imaging, or clinician's judgment 
5) Active infection of the genitals, vagina, cervix, uterus, adnexa, or urinary tract  
6) Active pelvic inflammatory disease 
7) Currently using an intrauterine device (IUD), including Mirena™ device, and 
unwilling to remove the IUD 
8) Presence of an implantable contraceptive device (e.g., Essure®) protruding 
into the uterine cavity 
9) Active sexually transmitted disease (STD) at the time of ablation  
10) Presence of bacteremia, sepsis, or other active systemic infection  
11) Currently on anticoagulants  
12) Known clotting defects or bleeding disorders  
13) Currently on medications that could thin the myometrium, such as long-term 
steroid use (except inhaler or nasal therapy for asthma or other pulmonary 
condition)  
14) Previous medical/surgical treatments, or has other conditions, that could lead 
to anatomic/pathologic weakness or thinning of the myometrium (Classical 
caesarean section and transmural myomectomy are examples of such 
treatments that may interrupt the integrity of the uterine wall) 
15) Any general health, mental health or social situation which, in the opinion of 
the investigator, could represent an increased risk for the patient, or the 
ability of the patient to complete study requirements  
16) Known/suspected abnormal uterine/pelvic anatomy or condition, such as 
frozen pelvis  
17) Abdominal, pelvic or gynecological malignancy 
18) Untreated/unevaluated cervical dysplasia, except cervical intraepithelial 
neoplasia I (CIN I)  
19) Previous endometrial ablation procedure  
20) Abnormal or obstructed, or perforated cavity as determined by investigator 
via standard clinical practices (e.g., hysteroscopy, saline infusion 
sonohysterography).  This includes, but is not limited to:  
a. Septate or bicornuate uterus, arcuate uterus or other congenital 
malformation of the uterine cavity  
b. Pedunculated or submucosal myomas distorting the uterine cavity or not 
fully resected  
c. 
Polyps larger than 1 cm  
21) Intramural or subserosal myomas > 3 cm in size, or any myoma that distorts 
the uterine cavity  
22) Any patient who is currently participating or considering participation in any 
other research of an investigational drug or device 
Study Management 
MicroCube, LLC or its designee 

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Data Management, 
Safety Review & 
Clinical Events 
Committee (CEC) 
Coordination 
Avania 
100 Crowley Drive, Suite 216 
Marlborough, MA  01752  
Sponsor/Manufactur
er 
MicroCube, LLC 
47853 Warm Springs Blvd. 
Fremont, CA  94539 
 
 

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6 
BACKGROUND 
Menorrhagia (heavy menstrual bleeding) can have significant negative effects on the quality of life of 
women including medical complications, anemia, time lost from work, physical discomfort, lifestyle and 
psychological disruption, and increased health costs. 
Hysterectomy has traditionally been regarded as the definitive surgical treatment for menorrhagia. 
However, despite a 100% success rate (complete cessation of menstruation) and high levels of 
satisfaction, it is a major surgical procedure with significant physical complications and social and 
economic costs.  This led to “first generation” hysteroscopic endometrial ablation devices that utilize a 
resectoscope and electro-cautery tools to minimally invasively ablate the functional layer of the 
endometrium, thus preventing abnormal uterine bleeding.  
“Second-generation” GEA devices for ablating the lining of the uterus have been introduced in the market 
with the aim of providing simpler, quicker, safer, and improved outcomes.  These procedures involve 
destroying the endometrium using radiofrequency energy, heated saline (freely circulating in the uterus), 
heated fluid inside a balloon, cryosurgery, and microwave energy. On October 29, 2015, the Food and 
Drug Administration (FDA) issued a letter, “Dear Global Endometrial Ablation Manufacturer”, that 
provided guidance to future global endometrial ablation device manufacturers and explained the basis for 
an objective performance criterion (OPC):  
 
“Since 1997, the United States Food and Drug Administration (FDA) has approved five 
non-hysteroscopic global endometrial ablation (GEA) devices based on the results of 
randomized controlled trials (RCTs) that compared the safety and effectiveness of the 
GEA device to the same control – hysteroscopic rollerball ablation. Rollerball ablation is 
an older, well-known surgical technique used to treat heavy menstrual bleeding from 
benign causes. The study designs that supported the approval of the five GEA devices 
were very similar. They enrolled between 250 and 350 subjects using either a 1:1 or 2:1 
(device: control) randomization scheme and had comparable patient populations. The 
primary endpoint for all five studies was the reduction in menstrual blood loss measured 
by the Pictorial Blood Loss Assessment Chart (PBLAC), a validated menstrual blood loss 
scoring system. One of the inclusion criteria required a baseline PBLAC score of at least 
150 or 185, and the individual patient success criteria for effectiveness was defined as a 
PBLAC score of less than or equal to 75 at one year following the ablation procedure. For 
all subjects, pretreatment evaluation was performed to confirm the study eligibility 
criteria were satisfied (e.g., absence of cavity distortions, lesions that might interfere with 
the GEA therapy). The analysis population consisted of all subjects who presented for 
their scheduled treatment, having satisfied the study eligibility criteria (intent-to-treat). 
This analysis population included women who presented for treatment, but did not 
receive the planned therapy due to reasons such as identification of exclusionary 
pathology immediately prior to ablation, withdrawal of consent, etc. Patients with 
missing PBLAC scores at one year following the ablation procedures were considered 
treatment failures. A study was considered a success if the proportion of successes in the 
GEA group met a pre-specified non-inferiority margin compared to the proportion of 
successes in the rollerball ablation control group.  
 
Using a generalized linear mixed model with study as a random effect, the FDA 
determined that the average success rate across the five GEA devices was 75.6% (65.6%, 
83.5%) and 77.2% (66.5%, 85.2%) for the rollerball ablation control.  The FDA performed 

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additional analyses to evaluate the effect of baseline covariates on the primary endpoint, 
including age (above and below 40), baseline PBLAC score (at least 150), uterine sound (6 
to 12 centimeters), and presence of fibroids (< 3 cm).  Using analysis of covariance 
methods, the FDA found that none of these baseline covariates had a significant impact 
on the study results. Based on this analysis, the FDA identified an objective performance 
criterion (OPC) for the minimum success rate for effectiveness.  The OPC is 66% based on 
the lower bound of the 95% confidence interval of the average success rate for the five 
approved GEA devices.” 
 
The Minitouch System is an endometrial ablation device that is similar in principle to the “second 
generation” endometrial ablation devices.  The EASE Clinical Trial is being conducted to assess the safety 
and efficacy of the Minitouch System. 
6.1 
Summary of Pre-Clinical and Clinical Testing (Prior Clinical Experience) 
Pre-clinical testing for the Minitouch System demonstrates that the system performs as intended.  Tests 
include the following in which the Minitouch System met the required pre-specified acceptance criteria:  
• 
Design and Performance Verification 
• 
Materials Testing (Biological Safety and Biocompatibility) 
• 
Software 
• 
Electrical Safety and EMC 
• 
Usability 
• 
Environmental & Life Cycle Testing 
• 
Packaging/ Transportation Testing 
• 
Sterilization Validation 
• 
Dose Confirmation and Simulation Studies  
• 
Ex-Vivo Human Uteri Ablation 
The Minitouch System has been commercially available outside the United States (OUS) since 2011.  As a 
result, there is extensive clinical experience with the device.  Specifically:   
• 
To date, there have been over 4000 real-world clinical procedures completed by more than 180 
users at over 70 hospitals/centers predominantly located in the UK.  Of these, one (1 or 0.025%) 
incidence of bowel injury occurred during clinical use.  This event was attributed to procedural 
use errors and the patient was not an optimal candidate for the procedure. 
• 
Additionally, there are over 50 publications (abstracts) reporting the OUS clinical experience of 
the Minitouch System.  A safety analysis (review of all adverse events reported) was conducted. 
o 
A total sampling of 1,040 patients treated with the Minitouch System were included in the 
safety analysis. 
o 
A total of 14 events were reported in the literature and are summarized below.  The 
events were consistent with those expected to occur in patients undergoing endometrial 
ablation. 
 
Event Description/Terminology 
(as reported in the literature) 
Occurrence Rate 
[n (%)]  
(where N=1040) 
Infection (suspected or confirmed)  
5 (0.48%) 
Post-procedure pain/cramps  
7 (0.67%) 
Vasovagal episode 
2 (0.19%) 
The Minitouch pre-clinical and clinical data are detailed in the Investigator’s Brochure. 

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7 
STUDY OBJECTIVE 
7.1 
Device and Study Rationale 
The Minitouch Endometrial Ablation System is designed with the patient and user in mind to expand 
women’s access to menorrhagia treatments that are safe, effective, and a less invasive alternative to 
hysterectomy. 
To provide a benchmark against which to judge the safety and effectiveness of the investigational system, 
this study is a prospective, single-arm, non-randomized, multi-center clinical trial of the effectiveness of 
endometrial ablation with the Minitouch System versus the FDA identified OPC for GEA devices. All 
procedures will be performed using the Minitouch System manufactured by MicroCube. The goal of the 
current study is to support reasonable safety and effectiveness of the investigational product compared 
to currently FDA-approved GEA devices. 
7.2 
Study Objectives 
7.2.1 
Primary Objective 
The primary objective of this study is to demonstrate the safety and effectiveness of the Minitouch 
Endometrial Ablation System in treating patients with menorrhagia.  
The study will demonstrate the Minitouch System’s success rate at 12 months post-procedure exceeds 
the 66% OPC for minimum success rate of effectiveness developed by the FDA. 
The Primary Safety Objective is the reported rate of device or procedure-related SAE at 12 months post-
procedure.  Serious adverse events are expected to be rare (<1%). (8-13)    
The safety endpoint at 24 and 36-months will include all device or procedure-related adverse device 
effects, SAEs and UADEs defined in Section 14 Adverse Event Reporting. 
7.2.2 
Secondary Objective 
Secondary objectives of this study are to evaluate improvement of quality of life, patient and investigator 
satisfaction, and the need for medical or surgical intervention to treat abnormal bleeding (as determined 
necessary by the study investigator) in the 12 months following the ablation procedure.   
8 
DEVICE DESCRIPTION 
8.1 
System Overview 
The Minitouch Endometrial Ablation System (Minitouch System) is a global endometrial ablation (GEA) 
device intended to treat menorrhagia by ablating the endometrium of the uterus.  
The Minitouch System consists of two main components: 
Minitouch System Components 
Product Number 
x 
Minitouch Hand Piece (Hand Piece) 
4501 
x 
Minitouch Generator (Generator) 
4001-01 
The Generator consists of four (4) main modular components and accessories (Power Cord & Stand Kit): 
 
Generator Components 
Product Number 
x 
Central Unit (CU) 
4002 
x 
Display 
4003 

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Generator Components 
Product Number 
x 
Inter-connecting Cable (ICC) 
4004 
x 
Keypad 
4005 
x 
Power Cord NEMA 5-15 (US) 
4006 
x 
Stand Kit 
o 
Base 
4007 
o 
Swing Arm 
4008 
o 
Dock  
4009 
 
 
Figure 8-1:  Minitouch Endometrial Ablation System 
 
The Hand Piece is a sterile, single-use energy applicator.  It is slim, flexible and atraumatic, and designed 
for transcervical access to the uterine cavity without requiring dilation of the cervix.  It is used exclusively 
with the Generator for delivering microwave energy to the uterine cavity.   
The Generator is a non-sterile, reusable, line-powered, modular system intended for generating, 
delivering and monitoring microwave energy.  The Generator is used exclusively with the Minitouch Hand 
Piece.  The Generator software version used in the EASE Clinical Trial is R02-02-02.  
The Minitouch System has no gas or fluidic systems or other consumables.  Refer to the Instructions for 
Use for additional details regarding the Minitouch System. 
8.2 
Principle of Operation 
Heavy menstrual bleeding (HMB), also called menorrhagia, can be treated by ablating the endometrial 
tissue of the uterus.  The endometrial lining of the uterus contains most of the endometrial tissue. 
Additionally, some endometrial tissue may protrude into the myometrium making the endomyometrial 

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junction more of a zone rather than a surface. The endometrial layer and the junctional zone together 
form the Target Tissue for ablation.  The Target Tissue is approximately in the shape of a triangular pillow, 
with the two cornua and the internal os of the uterine cavity forming its three corners.  It is thickest in the 
mid-uterine section, up to 20mm thick, and tapers off towards the edges and corners.  Refer to Figure 8-2 
below.  
 
 
Figure 8-2: Target Tissue Diagram (Left: Mid Coronal View, Right: Mid Sagittal View) 
 
The goal of the procedure is to safely ablate all of the Target Tissue in order to ensure that no endometrial 
tissue remains viable after the procedure.  
8.3 
Proposed Indications for Use (IFU) 
The Minitouch Endometrial Ablation System is intended for ablation of the endometrial lining of the 
uterus for the treatment of menorrhagia (heavy menstrual bleeding) due to benign causes in 
premenopausal women for whom childbearing is complete.  
8.4 
Device Instructions 
A comprehensive Instructions for Use (IFU) for the Minitouch Endometrial Ablation System, including 
warnings and precautions, has been created.  Please refer to the most current version for complete 
details on preparation and procedural use of the device. 
9 
STUDY ENDPOINTS 
9.1 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint is a reduction in menstrual blood loss as assessed by the Pictorial 
Blood Loss Assessment Chart (PBLAC) data, a validated, patient self-reported menstrual diary scoring 
system.  All patients must have a baseline PBLAC score of ш150 with a documented history of excessive 
menstrual bleeding to document a clinical diagnosis of menorrhagia.   
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without incidence of additional interventions or treatments for bleeding prior to the 12-month follow-up 
Internal Os
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o
Total procedure energy in joules
o
Anesthesia regimen
o
Procedure-related pain at pre-procedure (baseline), discharge and 24-hours post-
procedure
o
Need for cervical dilation
10 STUDY DESIGN 
This study is a prospective, multi-center, open-label, single-arm, clinical investigation to evaluate the 
Minitouch Endometrial Ablation System in up to 126 premenopausal women with menorrhagia.  The 
treatment procedure may be performed in an office setting or ambulatory / outpatient surgery 
centers/operating room (OR).  
Candidates will be identified via review of existing patient records and, if necessary, as a result of IRB-
approved recruitment advertisements (see Figure 10-1: Study Execution Diagram).  Study staff will 
confirm general eligibility and identify already existing SOC (standard of care) testing which may be 
applied to the trial. 
Study staff will obtain written informed consent as outlined in Section 11.5 Informed Consent. 
Screening may require more than one visit.  The first visit requires documentation of written informed 
consent and it is recommended that the visit include patient training on the method of collecting PBLAC 
diary data, a validated patient self-reported menstrual diary scoring system. (2) 
A subsequent visit may occur after approximately one month, and after completion of the PBLAC diary. 
The subject will return the completed PBLAC diary and the site personnel will confirm menorrhagia with a 
PBLAC a score of шϭϱϬ.  Then the patient will continue screening for additional eligibility assessments as 
outlined in Figure 10-1: Study Execution Diagram and Section 12.3 Screening Visits. 
Patient enrollment occurs on the day of the treatment following confirmation of eligibility.  Once 
confirmed, then the patient may undergo the Minitouch procedure.  One day after procedure, the study 
staff will contact the patient to assess the patient’s procedure-related pelvic pain level utilizing the NRS 
(0-10 scale).  Every effort should be made to ensure the 24-hour contact is conducted even if the window 
falls on a weekend.  The follow-up visits will occur at 2 weeks, 3 months, 6 months and 12 months, 24 
months, and 36 months post-procedure.  Total study duration for a Patient is approximately 37 months, 
including one month of pre-enrollment assessment, and 36 months post-treatment follow up.   

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*NOTE:  Final eligibility must be confirmed by the investigator prior to procedure initiation.   
 
Figure 10-1: Study Execution Diagram 

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11 PATIENT ENROLLMENT AND SELECTION 
11.1 Study Population 
The target patient population is adult females age 30 - 50 years old that meet the eligibility criteria as 
outlined in Section 11.3 Patient Selection Criteria.  All patients must sign the study-specific informed 
consent form and meet all inclusion criteria and have no exclusion criteria.   
11.2 Prescreening 
The investigators may prescreen prospective candidates prior to consent by reviewing current medical 
files to assess eligibility according to the selection criteria.  Applicable testing or information obtained in 
standard of care medical visits or obtained via recruitment services may be utilized for the study if the test 
was completed within the validity windows. 
No prospective protocol-specific testing or medication changes shall occur until the informed consent 
form (ICF) is signed by the patient and the delegated clinical site personnel.   
11.3 Patient Selection Criteria 
Patients who meet the inclusion criteria and do not fulfill any of the exclusion criteria will be eligible for 
participation in this study. 
11.3.1 Inclusion Criteria 
Patients eligible for inclusion in this study must fulfill the following criteria: 
1)
Female patient age 30 to 50 years
2)
Excessive menstrual bleeding due to benign causes
3)
Uterine sounding depth measurement of 6.0 – 12.0cm (external os to internal fundus)
4)
A minimum uterine cavity length of 4.0cm (internal os to internal fundus)
5)
ŵŝŶŝŵƵŵW>ƐĐŽƌĞŽĨшϭϱϬĨŽƌϭŵenstrual cycle (obtained during screening) and must also
have a documented history of excessive menstrual bleeding prior to study enrollment
6)
Endometrial biopsy within 12 months prior to treatment procedure with no abnormal pathology
7)
Premenopausal at screening ĂƐĚĞƚĞƌŵŝŶĞĚďǇ&^,ŵĞĂƐƵƌĞŵĞŶƚчϰϬ/hͬ>ǁŚĞŶĂŐĞŝƐ> 40
years
8)
Patient agrees to use a reliable form of contraception during the study, and follows these
requirements:
a.
If a hormonal birth control method is used for contraception, the patient must have
ďĞĞŶŽŶƐĂŝĚŵĞƚŚŽĚĨŽƌшϯŵŽŶƚŚƐƉƌŝŽƌƚŽthe onset of the screening menstrual cycle
and agrees to remain on the same hormonal regimen through the initial 12-month
follow-up (pills, injections, patches, rings, implants)
b.
Patient also agrees to not use hormonal birth control during the first 12-month post-
treatment follow-up period if they were not using hormonal birth control during the 3
months prior to treatment
9)
Ability to provide written informed consent
10) Patient is literate and clearly demonstrates understanding on how to use PBLAC after training
11) Patient agrees to the following during the study:
a.
No initiation of hormonal contraception or any other medical intervention for bleeding
b.
Attend all follow-up exams and submission of completed PBLAC diaries through the 36-
month follow-up timepoint

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c.
Exclusive use of study-provided sanitary products and submission of completed PBLAC
diaries through the 12-month post-treatment follow-up
11.3.2 Exclusion Criteria  
Patients will be excluded from this study if they meet any of the following criteria: 
Patient Conditions: 
1)
Pregnant, or desires to retain fertility
2)
Current or documented history of endometrial hyperplasia
3)
Active endometritis
4)
Clinically significant or suspected adenomyosis indicated by patient complaints, imaging or clinician's
judgment
5)
Active infection of the genitals, vagina, cervix, uterus, adnexa or urinary tract
6)
Active pelvic inflammatory disease
7)
Currently using an intrauterine device (IUD), including MirenaTM device, and unwilling to remove the
IUD
8)
Presence of an implantable contraceptive device (e.g., Essure®) protruding into the uterine cavity
9)
Active sexually transmitted disease (STD) at the time of ablation
10) Presence of bacteremia, sepsis, or other active systemic infection
11) Currently on anticoagulants
12) Known clotting defects or bleeding disorders
13) Currently on medications that could thin the myometrial muscle, such as long-term steroid use
(except inhaler or nasal therapy for asthma or other pulmonary conditions)
14) Previous medical/surgical treatments, or has other conditions, that could lead to anatomic/pathologic
weakness or thinning of the myometrium (Classical caesarean section and transmural myomectomy
are examples of such treatments that may interrupt the integrity of the uterine wall)
15) Any general health, mental health or social situation which, in the opinion of the investigator, could
represent an increased risk for the patient, or the ability of the patient to complete study
requirements.
Patient Anatomy: 
16) Known/suspected abnormal uterine/pelvic anatomy or condition, such as frozen pelvis
17) Abdominal, pelvic or gynecological malignancy
18) Untreated/unevaluated cervical dysplasia, except cervical intraepithelial neoplasia I (CIN I)
19) Previous endometrial ablation procedure
20) Abnormal or obstructed, or perforated cavity as determined by investigator via standard clinical
practices (e.g., hysteroscopy, saline infusion sonohysterography). This includes, but is not limited to:
a.
Septate or bicornuate uterus, arcuate uterus or other congenital malformation of the uterine
cavity
b.
Pedunculated or submucosal myomas distorting the uterine cavity or not fully resected
c.
Polyps larger than 1 cm
21) Intramural or subserosal myomas > 3 cm in size, or any myoma that distorts the uterine cavity
General Exclusions 
22) Any patient who is currently participating or considering participation in any other research of an
investigational drug or device

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11.4 Rescreening  
At the discretion of the investigator, a patient who previously failed screening may be rescreened.  All 
screening tests, including those conducted prior to rescreening, must still occur within the validity 
windows.  
11.5 Informed Consent 
IMPORTANT:  The Code of Federal Regulations requires that the consent form signed by the Patient 
must be dated at the time consent is given.  Also, medical records must contain documentation that 
informed consent was obtained prior to participation in a study.  (21 CFR Parts 50 and 812) 
The Investigator may determine whether potential Patients are interested in participating in an 
investigation, but shall not request the written informed consent of any Patient to participate, and shall 
not allow any Patient to participate before obtaining Institutional Review Board (IRB) approval and prior 
to receiving documentation of FDA approval from the Sponsor.  The consent process shall begin before 
care is altered beyond the scope of a routine comprehensive examination for the purpose of participating 
in this study. 
All Patients in this research study should be completely informed about the purpose, duration, and 
pertinent details of the study.  If the informed consent is amended by the Sponsor during the study, the 
investigator is responsible for ensuring the IRB reviews and approves the amended form.  The informed 
consent must be obtained using a written form that has been approved by the IRB and includes all Basic 
Elements of Informed Consent and pertinent Additional Elements (21 CFR Part 50.25).  The informed 
consent discussion and process with the potential study subject shall be documented in progress/clinic 
notes or other source documentation.  In the event a potential participant is unable to be seen in person, 
alternative methods of consenting (via telemedicine, including, but not limited to phone call, video or 
virtual office/remote visit, electronic signature or any combination of these methods) is allowed provided 
the consenting process is thoroughly documented in the study records and the signed consent form is 
maintained in the study records.  
The Investigator must keep the original signed copies of all consent forms in the Patient’s medical records 
and provide a copy to each Patient.  If new information becomes available during the course of the study, 
the information will be provided to new and existing patients, and if relevant, request existing patients to 
confirm their continued participation in the study by signing an amended informed consent or consent 
addendum. 
11.6 Patient Privacy 
The investigator agrees to comply with all applicable federal, state, and local laws and regulations relating 
to the privacy of patients’ health information, including, but not limited to, the Standards for Individually 
Identifiable Health Information, 45CFR Parts 160 and 164 and in accordance with the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), which states all patients should be informed of 
potential uses and disclosures of their medical information for research purposes, and their rights to 
access information about them by covered entities.  Each Investigator will follow the procedures for 
securing HIPAA compliance as directed by their respective IRB or Privacy Board, and to obtain written 
authorization to use and disclose patient information for all clinical research and research involving 
questioning of the patient’s or patients’ physician(s).  Per individual site procedures, this authorization 
may be included as part of the patient informed consent form. 

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11.7 Strategies for Recruitment and Retention 
Patients will be recruited through a variety of media.  Patients may be actively recruited through IRB-
approved web-based advertising, television, radio, and newspaper ads.  Patients will be financially 
compensated for their study participation.  The amount of compensation and schedule of payments will 
be documented in the ICF.  
11.7.1 Special Population 
This study will not focus on any particular subset of patients based on ethnicity or race. Further, no 
patient will be excluded from the study on the basis of racial or ethnic origin.  The racial and ethnic 
composition of the study is expected to represent the demographics of the typical population seeking 
relief menorrhagia in the geographical area around the investigational sites.  The age of the patients will 
typically be in the 30 – 50 year old range, the most common ages for menorrhagia.   
No patients from the vulnerable population shall be enrolled in the trial.  Specifically, elderly patients will 
not be included because these women are likely post-menopausal; and pediatric patients will not be 
included in this study because they do not meet the minimum age criteria and because it would be 
improper to have them undergo a procedure that would limit their potential fertility on a permanent 
basis.   
11.7.2 Control of Bias Section 
Upon receipt of IRB/ethics approval, patients with menorrhagia will be considered for the study until the 
site reaches its enrollment goal.  Careful documentation will be kept tracking potential patients’ eligibility 
and consent acceptance or rejection. To maintain a balanced population in the study, no single 
investigational site will be permitted to enroll more than 35% of the entire study population. 
Non-response bias will be prevented by offering reasonable expense reimbursement and incentives to 
participate in the study.  Every effort should be made to send appointment reminders to facilitate 
completion of study visits within study windows.  
11.8 Patient Discontinuation and Replacement 
Patients are free to terminate their participation (with or without reason) in the study at any time. 
Likewise, a patient may be terminated from the study by the investigator or the Sponsor, MicroCube, at 
any time if either investigator or Sponsor determines that it is not in the patient’s best interest to 
continue participation.  Enrolled patients that are terminated because of lack of compliance to protocol 
will not be replaced and will be considered lost to follow-up.  If a patient is terminated prior to the 12-
month follow up visit, this patient will be considered a treatment failure.   
11.8.1 Reasons for Termination 
Every patient should remain in the study until completion of the 36-month follow-up period.  Whenever 
possible, an exit visit should be conducted to record reason(s) for withdrawal, retrieve study materials 
(PBLAC diaries) and complete relevant visit assessments such: AEs, concomitant medications, patient’s 
menstrual status, NRS for dysmenorrhea-related pain and MIQ.  Conceivable reasons for early patient 
discontinuation may include, but are not limited to, the following: 
x 
Patient Withdrawal (voluntarily terminates consent):  Patient participation in this clinical study 
is voluntary.  The patient may choose to discontinue participation (refuse all subsequent testing) 
at any time without loss of benefits or penalty.  

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x 
Discontinuation:  Patient participation may be discontinued by the patient or investigator 
because of a treatment modality change, organ transplant, transfer, death or prolonged 
hospitalization. The Sponsor may also decide to discontinue the testing of the study device.  
x 
Investigator-initiated Termination: The Investigator may terminate the patient’s participation 
without regard to the patient’s consent if the Investigator believes it is medically necessary. In 
addition, the following circumstances may require early termination: 
o 
Patient is unable or unwilling to cooperate with study staff;  
o 
Emergence of clinically relevant serious adverse events, laboratory abnormalities or 
other medical condition or situation occurs such that continued participation would 
not be in the best interest of the patient;  
o 
Pregnancy 
o 
Death 
x 
Exclusion Criterion Discovered After Enrollment: A small number of patients may be enrolled 
despite meeting an exclusion criterion. This will be documented by the study personnel on the 
eCRF and will be considered a protocol deviation (PD), not termination.  
x 
Lost-to-Follow-up:  This category accounts for patients whose status is unclear because they fail 
to appear for study assessments/visits without stating intention to terminate consent.  The data 
from this patient is still eligible for the intent-to-treat dataset.  Site personnel should make all 
reasonable efforts to locate and communicate with the patient, at each contact time point, 
including: 
A minimum of three (3) telephone calls to contact the patient should be attempted.  Each attempt 
should be recorded in the patient’s medical record, including date, time, and initials of site personnel 
attempting the contact. 
If telephone calls are unsuccessful, a certified letter (with mailing receipt and electronic confirmation 
of delivery) should be sent to the patient.   
If the above-mentioned attempts at communicating with the patient are unsuccessful, the patient 
will be considered lost-to-follow-up.   
NOTE: If the patient is contacted, the patient is no longer considered lost-to-follow-up and study 
visits will resume at the next applicable time point.  
In all cases, the reason(s) for withdrawal, if given, must be recorded on the appropriate eCRF and in the 
patient's medical record.  If more than one reason is cited for withdrawal, study personnel must identify 
the most significant reason and record this reason on the eCRF.  Investigators must also report all patient 
withdrawals to their IRB as defined by their institutions’ procedures.  Patients who withdraw or are 
withdrawn from the study or are lost to follow-up will not be replaced.  
11.9 Point of Enrollment 
A consented patient will be registered into the study EDC (eCRFs) and a unique subject identification 
number at the time of registration will be issued via the EDC.  All data will be entered in the study EDC.  If 
a patient later declines to participate, or is excluded from enrollment, the investigator will note the 
reason for non-participation in the study EDC.  
A patient is considered enrolled when the following milestones have occurred: (1) the ICF is signed, (2) all 
applicable screening has been successfully completed, and (3) all study inclusion criteria and no exclusion 
criteria are met.  Since the final selection criteria are re-assessed prior to procedure initiation on the date 

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of treatment (e.g.: pregnancy test, current medications, active infections) the patient may not be enrolled 
until that date.  Specifically, final eligibility must be confirmed by the investigator prior to initiating the 
Minitouch procedure.   
For additional clarity, a consented patient that does not proceed to treatment for any reason (such as 
screen failure, declines treatment or participation), is categorized as consented-enrolled.  A qualified 
patient in whom the Minitouch procedure is initiated is categorized as treated-enrolled. 
11.10 Completion of the Clinical Investigation 
The completion of the clinical investigation shall be the last visit of the last subject and when follow-up is 
complete for the clinical investigation, whether the clinical investigation concluded according to the 
protocol or was terminated prematurely.   
12 STUDY VISIT INSTRUCTIONS 
12.1 Schedule of Events   
This section describes the timing for required testing and procedures during screening and in follow-up.  
All references to a study visit throughout the protocol are inclusive of visits conducted in person or via 
telemedicine visit (phone call, video, virtual office/remote), both of which are acceptable for purposes of 
trial conduct.  The overall schedule of events is shown below.  Results from these assessments will be 
captured in the patient’s medical record or on source documents, and eCRFs.  All study visit windows will 
be calculated based on the day of procedure (Day 0) and one month will be calculated as 30 calendar 
days, one week as 7 calendar days.  Section 13 STUDY PROCEDURES / EVALUATIONS details the 
processes.   
The study primary safety/efficacy endpoint assessment is conducted at the 12-month follow-up visit.  
12.2 Validity Windows for Baseline Testing 
All Baseline activities, including prescreening and rescreening testing must be conducted within the 
validity window.  Review testing dates prior to procedure to ensure that all required activities have been 
conducted within window as outlined in Table 12-1 below.   
For example, the assessment of the patient’s medical and surgical history must have occurred no more 
than 6 months prior to the date of treatment.  If that assessment is outside of that validity window, then 
reassess the subject’s medical and surgical history prior to the procedure.  
Table 12-1: Validity Windows 
 
Screening Activity 
Validity Window 
(where 6 months = 180 calendar days; and 
12 months = 365 calendar days) 
Demographics 
6 Months 
Medical and surgical history 
6 Months 
Documented history of excessive menstrual bleeding  
6 Months 
Physical examination 
6 Months 
Pap-Smear 
12 Months 
Transvaginal ultrasound 
6 Months 
Endometrial biopsy  
12 Months 
Sonohysterography / hysteroscopy 
6 Months 
Complete Blood Count 
6 Months 
Serum FSH 
6 Months 
Urine Pregnancy Test 
6 Months 

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Table 12-1: Validity Windows 
Screening Activity 
Validity Window 
(where 6 months = 180 calendar days; and 
12 months = 365 calendar days) 
Urine Dipstick Pregnancy Test (Day of Procedure) 
24 Hours 
STD Tests 
6 Months 
PBLAC 
6 Months* 
Menorrhagia Impact Questionnaire  
6 Months 
Dysmenorrhea-related pain 
6 Months 
* If the qualifying PBLAC diary was completed more than 3 months prior to the date of planned treatment, the 
investigator must verbally confirm with the subject that she continues to experience heavy menstrual bleeding, i.e.,
there has not been a clinically significant change in her menstrual status.  It will be left to the investigator’s judgment
whether another monthly PBLAC diary is warranted to reconfirm eligibility prior to treatment.
12.3 Screening Visits  
Before conducting any study-specific procedures, including modifications of medications, obtain written 
informed consent (See Section 11.5, Informed Consent) and register the patient in the EDC to obtain a 
unique patient identification number. 
Site personnel may use their medical judgment to best organize patient eligibility testing in a way that 
optimizes data collection and minimizes invasive testing.  Utilize the guidance in Sections 12.1 Schedule of 
Events and Section 12.2 Validity Windows for Baseline Testing. 
The screening process may require more than one visit to accomplish all the screening requirements. 
Then final eligibility must be confirmed by the investigator prior to procedure initiation.   
12.3.1 Suggested Order of Events:  
1.
Written informed consent
2.
Determine if any SOC testing may be used
3.
Demographic data
4.
Medical and surgical history
5.
Concomitant Medications / Treatments
6.
Patient PBLAC training and testing
7.
PBLAC diary and sanitary supply distribution (pads/etc.)
8.
Urine pregnancy test (to rule out pregnancy prior to proceeding with invasive diagnostic testing)
9.
Physical examination (to include height, weight and BMI)
10. Pap Smear
11. Endometrial biopsy
12. Ultrasound
13. Sonohysterography or hysteroscopy
14. Hematology/CBC
15. As needed, STD testing
16. Serum FSH
17. Menorrhagia Impact Questionnaire (MIQ)
18. Dysmenorrhea-related pain
19. If eligible, schedule procedure
12.3.2 Pictorial Blood Loss Assessment Chart 
PBLAC data collection is the most important assessment in this study.  It is the endpoint efficacy measure, 
it may be the most difficult criterion to meet with the requirement of a score of ш150, and its 

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administration may require more than one visit.  Details on administrating PBLAC are provided in Section 
13.11 PBLAC Diaries. 
12.3.3 Screen Failures 
Candidates who sign an informed consent form and fail to meet the inclusion and/or exclusion `criteria or 
who terminate from the study prior to treatment initiation are defined as screen failures.  Screen failures 
are excluded from participation in the study.  In some cases, subjects may be rescreened (See 11.4 
Rescreening).  If needed, obtain guidance from the Sponsor clinical staff to determine if a screen failed 
subject may be rescreened. 
12.4 Procedure (Day 0) – Enrollment / Discharge 
12.4.1 Procedure Visit Strategy 
On the day of procedure, first complete the reassessment of the selection criteria.  This will include urine 
pregnancy testing, vital signs, medication review, assessment for the presence of infection or STD. If the 
urine pregnancy test is positive, then the patient is a screen failure. 
Ensure that all existing tests remain within the validity windows. 
Once the final eligibility is confirmed, the patient is enrolled and may proceed to treatment. 
Prior to administration of procedure meds, have the subject complete the pelvic pain NRS prior to the 
procedure as a baseline.  Then the pelvic pain NRS will be assessed again at discharge and as part of the 
SOC 24-hour follow-up phone contact.   
Perform the procedure using the anesthesia of choice (as appropriate) and in accordance with the IFU. 
After the procedure, assess the patient for AEs, SAEs and UADEs, confirm/verify the patient’s 
understanding of the PBLAC diary completion instructions (retrain if necessary) and issue PBLAC diary and 
sanitary supplies.   
Schedule the SOC 24-hour follow-up phone contact and Week 2 post-treatment follow-up visit prior to 
discharging the subject.  
12.4.2 Suggested Order of Events 
1.
Review eligibility criteria
2.
Vital signs
3.
Baseline pelvic pain NRS
4.
Urine pregnancy test
5.
Anesthesia
6.
Minitouch treatment
7.
Post-procedure pelvic pain NRS – at discharge
8.
Assess adverse events
9.
Confirm Patient’s understanding of PBLAC completion, re-train if necessary (prior to discharge)
10.
PBLAC diary distribution and sanitary supplies (prior to discharge)
11.
Schedule the SOC 24-hour follow-up contact and Week 2 post-treatment follow-up visit
12.5 Standard of Care Contact After 24 hours 
Per standard of care procedures, the patient is to be contacted at the standard of care 24 hour (18-48 
hours) post-procedure.  The following will be assessed: 
1.
Procedure-related Pelvic Pain NRS

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2.
Concomitant Medications/treatments
3.
Assessment of adverse events
12.6 Week 2 Visit (± 7 days) 
Ensure that the visit is conducted within the visit windows.  The patient will not be expected to provide a 
PBLAC diary.  If a patient cannot attend a visit within window, then collect as much information as 
possible within window via phone, letter or email. 
12.7 Follow-up Visits Conducted 3 and 6 Months (± 2 weeks) After Treatment 
At these study visits, the patient will bring in her monthly PBLAC diaries.  Review all of the diaries during 
the visit to ensure that the diaries are being completed correctly.  Retrain the patient if necessary. 
Ensure that the visit is conducted within the visit windows.  If a patient cannot attend a visit within 
window, then collect as much information as possible within window via phone, letter or email.   
12.8 Endpoint Visit at Month 12 (± 4 weeks) 
This is the endpoint visit.  Ensure that the visit is conducted within window and if a patient cannot attend 
a visit within window, then collect as much information as possible within window via phone, letter or 
email.  Specifically, try to obtain the 12 Month PBLAC diary within window for all patients.   
12.9 Durability Visits Conducted 24 and 36 Months (± 8 weeks) After Treatment 
The 24 and 36-month visit may be conducted via phone, letter, email or in person as described in Section 
12.1.   
The 36-month visit is the final study visit.  Complete both the 36-Month Visit and the Study Completion 
eCRFs. 
12.10 Pre-Endpoint Termination Visit 
If a patient terminates from the study prior to the 12-month endpoint visit, collect as much as possible of 
the testing below.  
1.
Serious Adverse Event collection
2.
Concomitant Medications / Treatments
3.
PBLAC diary collection
4.
Menorrhagia Impact Questionnaire (MIQ)
5.
Dysmenorrhea-related pain (NRS)
6.
Patient Global Evaluation
7.
Investigator Global Evaluation
8.
Assessment of Adverse Events / Serious Adverse Events
12.11 Unscheduled Visits 
Collect source documentation from unscheduled visits as required to support the assessment of AEs, SAEs 
and UADEs.  Record these events in the appropriate upcoming eCRF visit module. 

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13 STUDY PROCEDURES / EVALUATIONS  
13.1 Prescreening 
Since this is standard of care information, varying information may be available.  Therefore, review 
existing testing to see if any may fit within the validity windows.  
The following clinical information to review for eligibility in prescreening is a suggestion only. Look for: 
o 
Female patient age 30 to 50 years, inclusive 
o 
Excessive menstrual bleeding due to benign causes  
o 
Ability to provide written informed consent 
Eliminate candidates with any of the following (not an inclusive list):  
o 
Pregnant 
o 
Known/suspected uterine cancer or pre-malignant conditions of the endometrium  
o 
Clinically significant or suspected adenomyosis  
o 
Known clotting defects, bleeding disorders or conditions that would affect menstrual 
bleeding or menses in general  
o 
Currently on medications that could thin the myometrial muscle, such as long-term 
steroid use (inhaler or nasal therapy for asthma or other pulmonary conditions are 
allowed)  
o 
Currently on anticoagulants 
o 
Previous medical/surgical treatments, or has other conditions, that could lead to 
anatomic/pathologic weakness or thinning of the myometrium (Classical caesarean 
section and transmural myomectomy are examples of such treatments that may 
interrupt the integrity of the uterine wall) 
o 
Any general health condition which, in the opinion of the investigator, could represent 
an increased risk for the patient or limit the ability of the patient to complete study 
requirements.   
13.2 Demographic Data and Medical History 
Demographics are to be collected on all patients during screening, including age (based on day of 
consent), sex, race, and ethnicity.  Height in centimeters (cm), body weight (kg, in indoor clothing but 
without shoes) and BMI will also be measured.  BMI shall be calculated as kg/m2.  The site should use the 
NIH website BMI calculator https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi-m.htm.  
Alternatively, BMI can be calculated in EDC so long as height (cm) and weight (kg) are entered accordingly.  
Relevant specific medical history and current medical conditions will be captured.    
Collect relevant medical diagnoses, specific medical history, surgical history and current medical 
conditions. In order to qualify, patients must have documented history or diagnosis of HMB, and 
therefore, source documents from non-participating institutions may need to be requested.  History may 
also include failed or contraindication to medical therapy, subject-reported historical use of sanitary 
products consistent with HMB, menstrual cycles that interfere with normal daily activities (e.g., work, 
social/leisure) due to prolonged duration or heavy menstrual flow, date of subject’s first perception of or 
when treatment was first sought for HMB, or assigned diagnosis code(s) consistent with HMB. 
Other eligibility criteria potentially identified from medical history (not an inclusive list): 
x 
Untreated/unevaluated cervical dysplasia, except cervical intraepithelial neoplasia I (CIN I)  
x 
Previous endometrial ablation procedure  
x 
Known/suspected abnormal uterine/pelvic anatomy or condition, such as frozen pelvis 

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x 
Previous medical/surgical treatments, or has other conditions, that could lead to 
anatomic/pathologic weakness or thinning of the myometrium (Classical caesarean section and 
transmural myomectomy are examples of such treatments that may interrupt the integrity of the 
uterine wall) 
x 
Known clotting defects or bleeding disorders  
x 
Abdominal pelvic or gynecological malignancy 
13.3 Physical Examination / Gynecological Exam 
A physical exam will be performed according to the Schedule of Events (at Screening/Baseline), as well as 
when judged necessary by the investigator or designee. Physical exam will be conducted per SOC (pelvic 
exam) and will include a Pap smear (at baseline only).  During the screening physical exam, consider the 
following criterion to detect clinically significant findings which are exclusionary:  
Any general health condition which, in the opinion of the investigator, could represent an 
increased risk for the patient or affect the effectiveness of GEA treatment, or limit the ability of 
the patient to fully participate in the study. 
13.4 Endometrial Biopsy, Ultrasound, Sonohysterography, Hysteroscopy 
Screening and gynecologic evaluations will be performed by a qualified and trained investigator and 
include endometrial biopsy, transvaginal ultrasound, sonohysterography or hysteroscopy to verify 
eligibility and prior to conducting the treatment procedure. Screening ultrasounds will be interpreted by 
experienced investigators using inclusion and exclusion criteria.  
Record the reference uterine sounding depth measurement.  Once these tests are completed, the patient 
must not undergo any other gynecological procedures prior to the Minitouch procedure. 
13.5 Vital Signs 
Vital signs including systolic blood pressure, diastolic blood pressure, temperature, respiratory rate, and 
pulse rate will be measured according to the Schedule of Events after at least 5 minutes at rest in the 
sitting or supine position.  
13.6 Concomitant Medications 
The use of concomitant medications is reviewed with the patient according to the Schedule of Events. 
Any changes in medication from the time of consent to the end of study should be recorded in the 
Concomitant Medications eCRF. 
13.6.1 Screening and Follow-up 
During screening, all medications should be captured, thereafter, any medication changes through the 
end of study should be recorded in the Concomitant Medications eCRF.  
Note that any intermittent (“PRN”) use of medication, or any new prescribed medication in follow-up 
may indicate the occurrence of, or a change to an ongoing Adverse Event.   
13.6.2 Contraception 
The patient must be on a reliable method of contraception for the duration of the study.  Special 
attention should be paid to medication review of hormonal contraception since the patient must have 
ďĞĞŶŽŶƐĂŝĚŵĞƚŚŽĚĨŽƌшϯŵŽŶƚŚƐƉƌŝŽƌƚŽthe onset of the screening menstrual cycle used for PBLAC 
diary completion and must remain on the same hormonal regimen through the 12-month follow-up visit. 

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Also, a subject may not begin hormonal contraception during the follow-up period if she were not on one 
at the time of screening.  
13.7 Adverse Events 
Serious adverse events (SAEs) and adverse events (AEs) are collected from the time of enrollment (on the 
day of the Minitouch procedure). Information on the collection and reporting of AEs and SAEs can be 
found in Section 14 ADVERSE EVENT REPORTING.  
13.8 Complete Blood Count (CBC) and Serum FSH 
Complete Blood Count (CBC) and Serum Follicle Stimulating Hormone (FSH) test results may be obtained 
from the patient medical records if the test was performed 6 months or fewer from the procedure date. 
Conduct additional testing as needed to confirm eligibility criteria. 
Premenopausal status is to be confirmed by FSH measurement ч40 IU/L when the patient is > 40 years 
old. 
13.9 Urine Pregnancy Test 
Patients will have urine pregnancy test at screening and urine dipstick pregnancy test at the Procedure 
Visit prior to treatment. Patients with a positive urine pregnancy test result must not be provided 
investigational treatment.  If a patient becomes amenorrheic after the procedure, it will be left to the 
investigator’s judgment whether to consider a pregnancy test to rule out a possible pregnancy for the 
cause of amenorrhea. 
13.10 Menorrhagia Impact Questionnaire (MIQ) 
Patients will be asked to assess their quality of life and impact of heavy menstrual bleeding (HMB) using a 
validated patient-reported outcome measurement. This questionnaire measures effects of HMB on 
limitations in social/leisure activities, physical activities, and ability to work.  
The questionnaire will be completed during baseline and at each follow-up visit. 
13.11 PBLAC Diaries 
Patients will self-report their menstrual blood loss as measured by validated Pictorial Blood Loss 
Assessment Chart (PBLAC).  The 12-month follow-up PBLAC score will comprise the primary endpoint data 
for this study.   
13.11.1 PBLAC Training 
During the site initiation visit (SIV) or as needed, the Sponsor or designee will train the authorized study 
staff to administer the PBLAC education to patients.  The study staff will train candidates regarding proper 
PBLAC completion and assess the patient’s understanding.   
Conduct PBLAC training early in the screening process, preferably at the first screening visit.  The subject 
will be provided with study materials including the PBLAC diary(ies), instructions and sanitary products. 
At the subsequent visit, score the PBLAC diary before resuming screening to be assured that the patient 
has completed it correctly and has a score of ш 150.  Once the patient passes the PBLAC assessment, 
complete any remaining screening testing. 
See Section 11.4 Rescreening for details regarding repeating PBLAC training or repeating PBLAC diary 
administration. 

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This will be assessed at all follow-up visits up, starting at the 3-month follow-up. 
13.14 Investigator Global Evaluation  
The investigator or designee will report their satisfaction with the patients’ study treatment using a 5-
point categorical scale: Very Satisfied, Satisfied, Not Sure, Dissatisfied, Very Dissatisfied. 
13.15 Device-related Issues or Device Deficiency/Malfunction 
A device-related issue or device deficiency/malfunction is a failure of the device to meet its performance 
specifications or otherwise perform as intended.  
During device set-up, treatment administration and post-treatment, site personnel and/or the PI will be 
requested to inspect and identify any defective parts.  The study Investigator (or designee) will keep 
documentation, notify the Sponsor and comply with Sponsor procedures for returned goods.    
13.16 Minitouch Procedure 
The Investigator is to confirm patient eligibility prior to initiating the procedure.  The Minitouch procedure 
is to be performed after the PI and any other delegated investigator have undergone the necessary 
training.  The PI/sub-investigators will perform the procedure in accordance with the IFU and this 
protocol.   See Section 12.4 Procedure (Day 0) – Enrollment / Discharge, for guidance on the sequence of 
events for this visit. 
13.16.1 Investigational Devices  
Refer to Section 18.3 Investigational Devices for details. 
13.16.2 Support 
The research coordinator should be present during the procedures to ensure that the study data are 
collected.  A Sponsor-designated technical support person may be present for the clinical procedure as 
support for the investigator. 
13.16.3 Procedure Medications 
The use and type of anesthesia is up to the discretion of the investigator and anesthesiologist.  This may 
include, but is not limited to, general, local (e.g., paracervical block) and/or IV sedation.  Pre-procedure 
prophylactic administration of over-the-counter NSAIDs and/or analgesics should also be considered for 
pain management. 
 
Eligible patients will receive a single treatment, meaning the procedure is completed one time in one 
clinical setting.  Single treatment includes four scenarios: 
a. Analgesic Regimen (No Sedation or Anesthesia) 
b. Sedation Regimen 
c. 
Single Anesthesia Regimen1 
d. Multiple Anesthesia Regimen 
 
1 Patient completes treatment with one anesthesia regimen.  Intermittent pauses in between energy 
delivery will be allowed to manage patient pain and to allow for U-value to increase if it drops to less than 
40 during procedure. 

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Record all medications provided prior to, during and after the procedure.  Determine if all prescribed pre-
and post-procedure medications were taken.  Inquire about the use of non-prescribed pain medication.  
Medications will be documented in the EDC (Concomitant Medication eCRF).  
14 ADVERSE EVENT REPORTING 
14.1 Adverse Event Definitions 
14.1.1 Adverse Event (AE):  
An adverse event (AE) is any untoward medical occurrence in a study patient which does not 
necessarily have a causal relationship with the medical device. This includes any unfavorable and 
unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease 
temporally associated with the use of a medical device, whether or not related to the medical device. 
It also includes any pre-existing condition that increases in intensity or severity or any new events 
after the patient had the procedure. (Also refer to Sections 14.1.5 and 14.1.6 for additional 
information.) 
14.1.2 Serious Adverse Events (SAEs) 
A serious adverse event is any untoward medical occurrence that results in one of the following: 
x 
Led to death 
x 
Led to serious deterioration in the health of the subject, that either resulted in 
o 
A life-threatening illness or injury, or 
o 
A permanent impairment of a body structure or a body function, or 
o 
In-patient hospitalization or prolongation, or 
o 
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
x 
Led to fetal distress, fetal death, congenital abnormality or birth defect  
x 
Note:  Planned hospitalization for a pre-existing condition or a procedure required by the 
protocol, without serious deterioration in health, is not considered a serious adverse event. 
14.1.3 Anticipated Adverse Device Effects Associated with Endometrial Ablation 
With all endometrial ablation procedures, serious injury or death can occur.  The following adverse 
effects could occur or have been reported in other EA studies and may occur when the Minitouch 
System is used.  The listing includes potential risks/effects associated with administration of 
anesthesia.  
Table 14-1:  Anticipated Adverse Device Effects of Endometrial Ablation 
More Commonly Reported Device/Procedural and/or Post-Procedural Complications (occurs in 20 or 
more patients out of 100) 

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x 
Cramping or pelvic pain 
x 
Nausea and vomiting  
x 
Vaginal bleeding or spotting 
x 
Vaginal discharge and/or unpleasant vaginal smell or burning or other abnormal sensation 
Other Common Possible Adverse Device Effects (occurs in 20 or less patients out of 100) 
x 
Abdominal pain or bloating 
x 
Adhesions 
x 
Backache 
x 
Cervical stenosis  
x 
Chills 
x 
Constipation 
x 
Diarrhea 
x 
Fever 
x 
Headache 
x 
Hematometra (collection of blood in the uterus) 
x 
Lightheadedness or fainting 
x 
Menometrorrhagia (abnormally heavy, prolonged and irregular uterine bleeding) 
x 
Post-ablation tubal sterilization syndrome (PATSS) 
x 
Skin rash and/or itching burning sensation  
x 
Weakness, fatigue, sleepiness, lack of concentration, dizziness 
Rare Adverse Device Effects (occurs in 5 or less patients out of 100) 
x 
Agitation 
x 
Air embolism (blood vessel blockage caused by an air bubble) 
x 
Cardiac complications 
x 
Cervical or vaginal laceration or tear 
x 
Complications leading to serious injury or death 
x 
Difficulty with defecation or micturition 
x 
Dyspareunia (painful intercourse) 
x 
Dysuria (painful urination) 
x 
Endometritis or Endomyometritis (inflammation of the uterine tissue) 
x 
Hemorrhage (excessive bleeding) 
x 
Hydrosalpinx (blocked fallopian tubes filled with fluid) 
x 
Infection or sepsis 
x 
Pelvic inflammatory disease (PID) 
x 
Pregnancy-related complications 
x 
Tissue injury (thermal, mechanical or electrical) 
x 
Uterine necrosis (uterine tissue death due to lack of blood supply) 

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x 
Uterine perforation (hole in the uterus) 
x 
Vulvar pruritis (itchiness of the vulva) 
14.1.4 Unanticipated Adverse Device Effects (UADEs) 
Any serious adverse effect on health or safety, any life-threatening problem or death caused by, or 
associated with a device, if that effect, problem, or death was not previously identified in nature, severity, 
or degree of incidence in the application; or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of patients per 21 CFR 812.3 and ISO 14155. 
14.1.5 Not Adverse Events 
x 
Pre-existing Conditions:  Any condition that is recorded in medical records and diagnosed prior 
to the Minitouch procedure, is considered a pre-existing condition.  This condition is not 
considered an adverse event unless there is a clinically significant worsening of that condition in 
terms of nature, severity, or degree of incidence.  For example, if a patient experiences HMB 
prior to procedure [e.g., PBLAC score = 300] and continues to experience HMB post-procedure 
[e.g., PBLAC score = 150 or ч 300], this is a pre-existing condition and should not be reported as 
an adverse event in the study). 
x 
Device Deficiencies or Malfunctions:  An undesirable device technical event is not an adverse 
event.  However, if a device deficiency or malfunction leads to a medically undesirable situation 
or an adverse device effect, then that event must be reported on an Adverse Event Form. 
x 
Lack of Effectiveness:  Lack of improvement of symptoms is not considered an adverse event.  
14.1.6 Adverse Events that do not require reporting to Sponsor 
For purposes of the trial, events that are typically expected to occur in and/or are associated with 
standard of care endometrial ablation therapies are not required to be reported unless they occur with 
greater severity or intensity than anticipated.  Examples of these commonly occurring anticipated post-
procedural events include: 
x 
Nausea and vomiting (usually with administration of anesthesia) 
x 
Post-operative pelvic or uterine cramping 
x 
Vaginal discharge (Note: Vaginal discharge usually happens during the first few days following 
treatment and may last as long as several weeks. It is generally described as bloody during the 
first few days, a mixture of blood and fluid for another week, then followed by a watery 
discharge that can be substantial at times. This is an anticipated symptom of the treatment and is 
not considered an adverse event unless the vaginal discharge suggests infection.) 
x 
Vaginal bleeding/spotting 
Note:  This listing of events is intended to provide guidance to Investigators for the purpose of adverse 
event reporting.  The investigator should utilize his/her own clinical judgment in evaluating adverse 
experiences, and may decide that the above events should be reported as adverse events based on site 
IRB/EC reporting requirements or the subject’s clinical condition.    

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14.2 Recording Adverse Events 
14.2.1 Adverse Event Evaluation and Categorization 
All AEs/ADEs will be assessed by the Investigator. Adverse events and Adverse Device Effects will be 
classified as serious or non-serious. Adverse Events are also qualified by intensity (severity), causality 
(relatedness), and expectedness.  
14.2.2 Intensity (Severity) 
x 
Mild: Mild or transient discomfort, without limitation or normal daily activities; no medical 
intervention or corrective treatment required 
x 
Moderate:  Mild to moderate limitation of normal daily activities; minimal medical intervention 
or corrective treatment required 
x 
Severe: Marked limitation of normal daily activities; medical intervention and corrective 
treatment required; possible hospitalization.  
Prior to analysis, all adverse events (AEs) will be coded using the Medical Dictionary for Regulatory 
Activities (MedDRA).  Based on these coded terms, treatment emergent AEs will be summarized by 
treatment period, by severity, relation to procedure and relation to device. 
14.2.3 Other Adverse Events 
The Investigator will monitor the occurrence of adverse events for each Patient during the course of the 
study.  All AEs will be listed on the adverse event case report forms.  All pre-existing medical conditions 
and baseline signs and symptoms will be recorded on baseline case report forms for medical history and 
signs and symptoms.  
Adverse events will be monitored until they are adequately resolved or explained. 
14.2.4 Determination of the Relationship (Causality) 
The Investigator, on the basis of his or her clinical judgment, should determine whether there is a 
reasonable possibility the investigational device or procedure caused or contributed to the event. 
Guidelines to assess AE/SAE/UADE are provided below: 
Unrelated:  The adverse event is determined to be solely caused by the underlying disease, 
disorder or condition of the patient, or attributable solely to other extraneous causes (unrelated to 
the device, device malfunction, or the procedure). 
Possibly related:  The adverse event has onset within a clinically relevant temporal relationship to 
exposure to the device or procedure and is plausibly at least partially caused by or aggravated by 
the use of the device, device malfunction, or the procedure. It must also meet one of the following 
criteria: (1) follows a known or easily foreseen pattern of response to device use or procedure and 
(2) is not fully attributable to the underlying disease, disorder or condition of the patient, or
attributable to other extraneous causes.
Probably related:  The adverse event has onset within a clinically relevant temporal relationship to 
exposure to the device or procedure and is more likely than not to be at least partially caused by or 
aggravated by the use of the device, device malfunction, or the procedure. It must also meet both 
of the following criteria: (1) follows a known or easily foreseen pattern of response to device use or 
procedure; and (2) is not fully attributable to the underlying disease, disorder or condition of the 

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patient, or attributable to other extraneous causes. In addition, if the adverse effect is reversible 
upon reoperation or device exchange, and such a procedure is done, the effect disappears or 
lessens in severity within the expected time interval. 
Definitely related:  The adverse event is clearly caused by the use of the device, device 
malfunction, or the procedure. It must meet all the following criteria: (1) has a clear temporal 
relationship between device exposure and onset of the event; (2) follows a known pattern of 
response to device use or procedure; and (3) is not reasonably attributable to the underlying 
disease, disorder or condition of the patient, or attributable to other extraneous causes. In 
addition, if the adverse effect is reversible upon reoperation or device exchange, and such a 
procedure is done, the effect disappears or lessens in severity within the expected time interval. 
14.3 Reporting Requirements for SAEs or UADEs  
It is the responsibility of the Principal Investigator to report SAEs or UADEs to the Sponsor within 24 hours 
of becoming aware of the SAE or UADE.  Notification should occur via completion of the eCRFs.  Reporting 
of the event to applicable regulatory bodies should occur per the established reporting criteria. For UADE 
reports, investigators are required to submit a report of a UADE to the Sponsor and the reviewing IRB as 
soon as possible, but in no event later than 10 working days after the investigator first learns of the event 
(§ 812.150(a)(1)).  Sponsors must immediately conduct an evaluation of a UADE and must report the 
results of the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 working days 
after the Sponsor first receives notice of the effect (§§ 812.46(b), 812.150(b)(1)). 
14.4 Medical Treatment for AEs, SAEs and UADEs 
Medical treatment for events occurring during and following the Minitouch treatment will be at the 
discretion of the investigator.  
15 CLINICAL EVENTS COMMITTEE 
A Clinical Events Committee (CEC) will be comprised of qualified multi-disciplinary individuals who are not 
investigators in the trial or a clinician at a trial site and who are independent of the Sponsor.  The CEC is 
responsible for adjudicating the safety aspects of this study based on the charter .  The composition, 
guiding policies, operating procedures and stopping rules (if safety concerns arise during their review of 
the study data) that govern the CEC will be described in a separate CEC Charter developed by the CEC 
members. 
16 RISKS AND BENEFITS 
16.1 Potential Risks 
The potential risks and benefits of participation in this study are identified in the ICF and are to be 
explained to the patient prior to participating in the study.  The potential risks are also summarized in the 
IFU.  It is not anticipated that there will be any additional risks to the patient with the use of the 
Minitouch System that are different than those associated with current second generation GEA 
procedures.  
16.1.1 Procedure Risks 
Potential adverse events that may be associated with a second-generation GEA procedure include but are 
not limited to events listed in Section 14.1.3 Anticipated Adverse Device Effects Associated with 
Endometrial Ablation.  With all endometrial ablation procedures, serious injury or death can occur. 

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16.2 Risk Management Procedures 
For several decades, endometrial ablation has been available as a treatment for HMB and subsequently, 
the potential risks associated with the therapy are well-known.  While no new risks have been identified 
regarding the Minitouch System for the proposed indications for use, the following measures have been 
or will be taken to mitigate risk for all patients participating in the EASE Clinical Trial: 
x 
Well-defined clinical protocol to enroll appropriate patients in the study. Specifically, eligibility 
criteria have been selected that exclude patients who are at higher risk for experiencing an 
anticipated adverse event in order to reduce the risks to patients who participate in this study.   
x 
Close monitoring of patients will take place during the investigational procedure and throughout 
the study, and adverse events will be recorded in the patients’ charts and on eCRFs. 
x 
Engineering testing has been performed on the Minitouch System to help mitigate risks to the 
patients due to product failure. 
x 
Investigators in this study will be selected based on their experience and competency to perform 
endometrial ablation and perform the research. 
x 
Investigational device training will be conducted at each initiated study center and appropriate 
training records will be maintained.   
x 
Ongoing monitoring of study data and results, including the use of an independent oversight 
committee: Clinical Events Committee.  
x 
As appropriate, Sponsor or designee will be onsite to support Minitouch procedures performed 
under the EASE Clinical Trial protocol.   
16.3 Potential Benefits 
The patient may experience clinically significant relief from their menorrhagia or dysmenorrhea 
symptoms.  There are no guaranteed additional benefits from participation in this study.  Information 
gained from the conduct of this study may be of no benefit to others with the same medical condition.  
17 STATISTICAL METHODS AND CONSIDERATIONS 
The Statistical Analysis Plan (SAP) for the study will describe the data sets to be analyzed, the methods of 
analysis, and the specific analyses to be conducted in support of the study’s primary and secondary 
endpoints.  Those key elements are outlined below. 
17.1 Analysis Cohorts 
Statistical analysis will use definitions listed below.  
17.1.1 Intent-to-Treat (ITT) Cohort 
All patients who are enrolled in the study (enrollment defined as patients who met all study eligibility 
criteria and in whom the procedure is initiated) are included in the Intent-to-Treat (ITT) cohort.   
The ITT cohort will be used for the following analyses (as defined in Section 9.1 & 9.2): 
x 
Primary safety and effectiveness analyses at 12-month follow-up visits. 
x 
Safety & effectiveness analyses at 24, and 36-month follow-up visits. 

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17.1.2 Per Protocol (PP) Cohort 
This cohort consists of all ITT Patients who are considered treatable patients, completed ablation therapy 
and attended 12-month follow-up visit.   
The PP cohort will be used for the following analyses: 
x 
Safety and efficacy outcome measures at 12, 24, and 36-month follow-up visits 
x 
 Secondary Analyses to assess amenorrhea rates, improvement of quality of life, evaluate patient 
and user (investigator) satisfaction. 
x 
Subgroup Analyses  
x 
Exploratory Analyses 
17.2 Analysis of Primary Efficacy Endpoint at 12-month 
The primary efficacy endpoint is binary (success/failure).  Success is defined as PBLAC score of <75 at the 
12-month follow-up assessment without incidence of additional interventions or treatments for bleeding
prior to the 12-month follow-up visit.  The proposed study’s primary hypothesis is:
Null Hypothesis (H0) = pminitouch ч OPC 
Alternate Hypothesis (H1) = pminitouch > OPC  
where pminitouch is the Minitouch Endometrial Ablation System success rate and OPC is 66% which is the 
FDA identified objective performance criterion (OPC) for global endometrial ablation (GEA) devices.  
The exact binomial test will be conducted to compare the investigational device success rate to OPC 
minimum success rate for effectiveness.  To achieve study success the measured success rate should 
exceed the 66% OPC. 
ITT with imputation will be utilized to test the primary hypothesis, such that all missing data are failures 
for the primary endpoint. The following imputation techniques will be conducted for sensitivity analysis: 
x 
Multiple Imputation (MI) using fully conditional specification (FCS) method, in which 
logistic regression is used to predict whether the missing value is likely to be a success or 
failure.  The number of imputations will depend on the fraction of missing information. 
x 
Tipping point, in which the numbers of successes or failures amongst missing data 
necessary to meet the primary endpoint hypothesis are determined. 
Fisher-Freeman-Halton test will be conducted to compare the success rates between investigational sites. 
Results will also be stratified and compared across relevant baseline characteristics including 
demographics. 
Alternate Hypothesis (H1) 
H0 
66% 
OPC 
76% 
83% 

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17.2.1 Study Power 
Utilizing a minimum effectiveness rate of 66% (OPC), an expected success rate of approximately 78% for 
Minitouch, and a one-sided alpha of 0.025, the study sample size required to obtain at least 80% power is 
114 Patients.  Assuming a dropout rate of approximately 10% at 12 months, the required enrolled sample 
size is determined to be 126 Patients.  
The 78% investigational device success rate is derived from other GEA studies recently conducted and 
published.  For sample size calculation, Minerva utilized an expected success rate of 78% (Laberge et al. J 
Minim Invasive Gynecol 2015;7:1169-77) and Aegea utilized an expected success rate of 76% (Levie MD, 
Chudnoff SG. J Minim Invasive Gynecol 2018; S1553-4650).  
Multiple scenarios were used to calculate the sample size.  Statistical Analysis Software (SAS) POWER 
procedure Z test for binomial proportion was utilized with the following fixed scenario elements: normal 
approximation method, 66% null proportion, 0.025 one-sided alpha, 80% nominal power, and null 
variance estimate.  
17.3 
Predictive Analysis 12, 24, and 36-month Efficacy Outcome 
Univariate analyses will be conducted using analysis of covariance (ANCOVA) to evaluate the effect of 
demographics, gynecologic history, procedure-related characteristics and diagnosis of COVID-19 or 
COVID-19 vaccination status on PBLAC score post procedure, while controlling for baseline PBLAC scores. 
17.4 
Analysis of Primary Safety Endpoint at 12-month 
The primary safety endpoint is the rate of device or procedure-related serious adverse events.  It will be 
evaluated 12 months post-procedure. 
17.5 
Analysis of All Safety Outcome 
All safety events reported in the study will be tabulated.  The study’s safety analysis focuses on specific 
device- or procedure-related safety events listed in Section 13.  Intra-operative and post-operative serious 
adverse event (SAE) and overall rates of AEs (number and percentage with 95% confidence interval) will 
be reported.  
The need for medical or surgical intervention to treat abnormal bleeding following the ablation procedure 
will also be reported.  
17.6 
Analysis of Secondary Endpoints 
No hypothesis will be tested with regards to secondary endpoints. Secondary endpoints will be reported 
using descriptive statistics along with sample size.  Measures of central tendency (mean, median, and 
mode) and of variation (range and standard deviation) for continuous variables.  Measures of frequency 
(count and proportions) for categorical variables. 
17.7 
Subgroup Analyses 
The following subgroup analyses will be performed for both treatment success (reduction of menstrual 
blood loss) and amenorrhea rates for the following timepoints during study follow-up: 12, 24, and 36-
months post procedure.   
•
Age (<40 years vs. >40 years)
•
Active bleeding at the time of the operative visit (Yes vs. No)

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•
Transverse or low segment C-section (Yes vs. No)
•
Anesthesia regimen (None vs. Sedation vs. Local Anesthesia vs. General Anesthesia vs.
Multiple)
•
Use environment (Office vs. Non-office)
•
Uterine sound depth (6-9.0cm vs. 9.1-12cm and 6-8.0cm vs. 8.1-10cm vs. 10.1-12cm)
•
Presence of anemia at Baseline defined as hemoglobin < 12 g/dL (Yes vs. No)
•
Presence of fibroids at Baseline (Yes vs. No)
•
Presence of ovarian cysts at Baseline (Yes vs. No)
•
Presence of any intrauterine pathology at baseline (Yes vs. No)
•
Contraceptive use (hormonal method vs. non-hormonal method)
•
COVID-19 Status (diagnosed with COVID-19 vs. did not have COVID-19)
•
COVID-19 Vaccination Status (vaccinated vs. not vaccinated)
The study is not powered for these subgroups, and therefore, there will be no hypothesis testing for the 
primary endpoints within these groups.  These analyses will be done using the PP population.   
17.8 
Exploratory Analyses 
The following exploratory analyses will be performed: 
•
Mean percent change in PBLAC score from Baseline per PGE Patient Satisfaction Category
Question 1 (Very Satisfied, Satisfied, Not Sure, Dissatisfied, Very Dissatisfied)
•
Average change in quantity of sanitary products used
•
Relation between Baseline PBLAC score and treatment success or failure
•
Change in pain medication use for dysmenorrhea from baseline to 12 months
Additional exploratory analyses may be performed. 
18 STUDY RECORD MANAGEMENT 
For the study duration the investigator will maintain complete and accurate documentation, including but 
not limited to, medical records, study progress records, source worksheets, laboratory reports, eCRFs, 
signed and dated informed consent forms, all relevant correspondence (e.g., with the IRB, Sponsor 
personnel/representatives, and other regulatory agencies), the protocol, and documentation for each 
deviation from the protocol, records of receipt, use, or disposition of each device, record of the exposure 
to the investigational device, adverse event records, information regarding patient discontinuation or 
completion of the study, any other supporting data, and any other records that FDA requires to be 
maintained by regulation or by specific requirement. 
18.1 Source Documentation 
Regulations require that an investigator maintain information in the patient’s medical records which can 
corroborate data collected on study eCRFs.  In order to comply with these regulatory requirements, at a 
minimum, the following information should be recorded in the patient’s study records: 

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x 
Medical history and physical condition of the patient prior to participation in the study sufficient 
to verify inclusion/exclusion criteria. 
x 
Dated and signed study progress or clinic notes on the day of entry into the study referencing the 
protocol number, site, unique patient ID number assigned, and a statement that informed consent 
was obtained. 
x 
Dated and signed notes from each patient’s visit. 
x 
All collected AE, SAE, UADEs and their resolution, including supporting documents such as 
discharge summaries and diagnostic test results. 
x 
Patient medical condition upon completion of or withdrawal from the study. 
Data recorded in the patient’s medical records will be reviewed for verification of agreement with critical 
data on the eCRFs as specified in the monitoring plan. The investigator/study personnel will allow the 
Sponsor (or designee) and appropriate regulatory authorities access to these records. If a non-study 
physician, at a non-study institution, sees a study patient regarding a study requirement or an AE, SAE or 
UADE, then a copy of the medical record will be copied and placed in the patient’s study records and 
made available for review.  
18.2 Data Collection and Electronic Case Report Form Completion 
All study data will be collected and recorded by authorized study personnel on the required electronic 
Case Report Forms (eCRFs). Identifiable patient information will not be recorded in the eCRFs. Patients 
will be assigned unique study identification numbers.  Only study site personnel directly involved with 
study and Sponsor, monitors or designee(s) will have access to the documentation that links the study 
identification numbers to identifying patient information. 
The eCRFs will capture information relevant to the patients’ clinical presentation, medical history, 
laboratory values, and results of clinical and/or gynecological testing. Follow-up clinical data will include 
laboratory assessments, current medications, physician office visits, hospitalizations, and/or adverse 
events that have occurred since study enrollment or from the prior visit.  
The site PI will be required to sign and date the completed eCRFs on the appropriate page(s) to verify that 
he/she has reviewed the recorded data, and assures its accuracy and completeness. 
18.3 Investigational Devices 
18.3.1 Labeling 
The Sponsor will label all investigational devices in accordance with FDA regulations per 21CFR 812.5. 
18.3.2 Ordering, Receiving and Storing Investigational Device 
The Sponsor will ship Investigational devices to a clinical site once the requirements for site activation and 
authorization to enroll are met. 
Components of the investigational device system will be shipped to each investigational site with a 
packing slip.  The packing slips will be verified to ensure that they reflect the correct shipping quantities 
and will be signed and dated by the study personnel upon receipt of the devices.  A copy of the signed 
packing slip should  be provided to the Sponsor or designee.   
Investigational devices shall be stored in a secure area.  The PI or an authorized designee will be 
responsible for maintaining control of and verifying each device’s disposition. 

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18.3.3 Investigational Device Accountability 
The Investigator shall maintain adequate records of the receipt, use, and disposition of the Investigational 
Device.  
Investigational devices will only be used with this clinical investigation. The principal investigator or an 
authorized designee shall keep device accountability log tracking documenting the receipt, use, return 
and disposal of the investigational devices, which shall include: 
a) the date of receipt and the signature of the individual who received the product(s), 
b) identification of each investigational device (batch number/serial number or unique code), 
c) the expiry date, if applicable, 
d) the date or dates of use, 
e) unique patient identification number, 
f) date when the investigational device was returned (for any reason), and 
g) the date of return of unused, expired or malfunctioning investigational devices, if applicable. 
This log must be maintained at each investigational site and must be filed in the regulatory binder.  At the 
end of enrollment, Sponsor or designee shall ensure that documentation of the final reconciliation of all 
devices is signed or initialed by the PI or authorized designee.     
18.3.4 Device Disposal or Return 
Devices are to be disposed utilizing the study site’s specific biohazard procedures unless return is required 
or requested by the Sponsor.   
Devices that did not work as expected (device deficiency or malfunction) or are involved with an adverse 
event during treatment may be returned. If a Sponsor representative is present, work with them to 
complete the device return. If not, then, please contact the Sponsor clinical staff as soon as possible to 
discuss the return of products.  The Sponsor will provide instructions for biohazard device return.  Return 
of these devices will be captured on the device accountability log.   
A Sponsor representative or designee will collect all unused devices remaining at the end of the 
enrollment period. 
18.4 Data Management and Processing 
Overall data management will be the responsibility of the study Sponsor or designee.  All data will be 
managed in a 21 CFR Part 11-compliant database.  Data edit checks will be performed and the study sites 
will be queried as needed to ensure completeness and accuracy of study data.  
All above-mentioned tasks will be performed according to the Data Management Plan and Sponsor or 
CRO SOPs.  Audits may be performed for quality assurance of procedures and data handling. 
19 TRAINING 
19.1 Site Training 
The investigator should have adequate resources and time to conduct the study properly and should have 
adequate number of qualified and trained staff to assist with conduct of the study. The investigator shall 
delegate tasks and responsibilities only to other investigational site personnel qualified by education, 
training and experience to perform delegated tasks. The investigator shall have direct oversight of all 

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delegation activities and shall document delegation of responsibilities. The investigator is responsible for 
ensuring all delegated staff has been properly trained on the protocol and their assigned study 
responsibilities.  A delegation log identifying all delegated duties and the individual to whom they have 
been delegated will be maintained at the investigational site and approved by the site principal 
investigator.  
19.2 Device Training  
Investigators responsible for treating subjects with the Minitouch will receive sufficient training to ensure 
competence in the execution of all aspects of the procedure.  Training may include hands-on experience 
with demonstration videos and didactic presentations.  Training will also include extensive review of the 
Instructions for Use (IFU).  Training for first use will be conducted before the first cases, and subsequent 
cases preceded by refresher training as necessary.  
20 MONITORING 
20.1 Site Monitoring Procedures 
All study monitoring activities will be managed and performed by the Sponsor or designee monitors.  
eCRFs will be source-document verified according to the monitoring plan.  The extent, nature, and 
frequency of on-site visits will be based on considerations such as study objectives and/or endpoints, 
study design and complexity, and enrollment rate.  These tasks will be performed according to relevant 
SOPs and the study monitoring plan.  The monitoring plan will describe in detail who will conduct the 
monitoring and at what frequency, and distribution of monitoring reports. It will focus on preventing or 
mitigating non-compliance and risks to critical data and processes. 
At regular intervals during the study, the Sponsor study monitors will contact the study sites via onsite 
and/or remote visits, telephone calls, emails and letters in order to review the study progress and eCRF 
completion and to address any concerns or questions regarding study conduct.  The number of 
monitoring visits and their duration will be conducted according to the monitoring plan. By verifying 
compliance, these activities will ensure: 
x 
The study is conducted in accordance with the study protocol, relevant Good Clinical Practice 
(GCP) and International Conference on Harmonization (ICH) guidelines, as well as in conjunction 
with 21 CFR Part 812, 50, 54, 56 and ISO 14155;  Protection of Human Patients (Informed 
Consent) (21 CFR Part 50), Financial Disclosure by Clinical Investigators (21 CFR Part 54), 
Institutional Review Boards (21 CFR Part 56), Investigational Device Exemptions (21 CFR Part 
812), the Declaration of Helsinki, the privacy requirements of the Health Information Portability 
and Accountability Act (HIPAA);  
x Adequate protection of the rights and safety of the informed patients involved in the study by 
thoroughly providing accurate and complete data; and 
x Quality and integrity of the data. 
The frequency and scope of periodic site visits will be determined according to the monitoring plan, but at 
a minimum, shall occur at least once per year.  Monitoring activities may include: review of the informed 
consent process and research authorization confirmation, regulatory document review, overall 
investigational plan adherence, GCP/ICH compliance, facility assessment, study staff assessment and 
additional study related functions that contribute to the safety of study Patients and the integrity of study 
data.  

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Investigators must provide adequate time and resources to the study and will be available to the study 
monitor and/or designee via telephone, and in person during site visits.  The Investigator will also provide 
the study monitor with a suitable working environment for review of study-related documents.  
20.2 Compliance 
20.2.1 Site Compliance 
The study at the investigational site may be subject to an audit by the Sponsor or its designees for quality 
assurance purposes, as well as inspection by appropriate regulatory authorities. 
In the event that an Investigator is contacted by a Regulatory Agency in relation to this study, the 
Investigator shall notify the study Sponsor immediately. The Investigator shall permit authorized 
representatives from appropriate regulatory authorities, at reasonable times and in a reasonable manner, 
to: 
x 
Enter and inspect any establishment where the device is held or records relating to the 
investigational device are kept, inspect and copy records relating to the investigational device 
use. 
x 
Inspect and copy records that identify Patients upon notice that the Regulatory Agency has 
reason to suspect that adequate informed consent was not obtained, or that reports required to 
be submitted by the Investigator to the Sponsor or IRB have not been submitted or are 
incomplete, inaccurate, false, or misleading. 
The Investigator must provide the Sponsor with copies of all correspondence that may affect the review 
of the current clinical investigation (e.g., Form FDA 483, Inspectional Observations, and Warning Letters). 
The study Sponsor may provide any needed assistance in responding to regulatory audits. 
20.2.2 Protocol Deviations 
All protocol deviations will be classified as major or minor and documented and discussed in the Clinical 
Study Report. 
A deviation is defined as any departure from clinical study requirements, including those cited within 
Good Clinical Practice (GCP) guidelines. Protocol deviations that affect the rights, safety, or welfare of 
human Patients must be reported to the study Sponsor as soon as possible from the occurrence of the 
deviation.  
Major protocol deviations are defined as any protocol deviation that affects the soundness of the data or 
a Patient’s rights.  A major protocol deviation is non-compliance with the approved protocol and trial 
requirements that may impact patient safety, affect the integrity of the data and/or affect the patient’s 
willingness to participate in the study.  
Examples may include: 
x 
Failure to meet all entry criteria;  
x 
Non-compliant with device treatment regimen 
A minor protocol deviation is non-compliance with the approved protocol and a trial requirement that 
does not impact Patient safety, compromise the integrity of the data and/or affect the Patient’s 
willingness to participate in the study. 
Protocol deviations must be reported to the IRB per the Institutional Review Board’s reporting 
requirements.  The occurrence of protocol deviations will be monitored by the study Sponsor and 

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designee for evaluation of Investigator compliance to the study protocol, GCP guidelines, and regulatory 
requirements.  Protocol deviations will be reviewed and evaluated by the study Sponsor or designee on an 
ongoing basis in accordance with the Protocol Deviation Management Plan, as applicable.  
21 QUALITY CONTROL AND ASSURANCE 
MicroCube or designee, a regulatory authority, or an IRB representative may visit the study site at any 
time during the study or after completion of the study to perform audits or inspections.  The purpose of 
these audits or inspections is to examine systematically and independently all study-related activities and 
documents to determine whether they were conducted in accordance to the protocol, GCP, and any other 
applicable regulatory requirements. Investigators should contact the Sponsor immediately if contacted by 
a regulatory agency about an inspection at their site.  
21.1 Selection of Sites and Investigators 
Site selection and qualification may be conducted by visits to the site in which the many aspects of the 
study and investigators obligations are discussed.  The Sponsor will ascertain the suitability of the 
investigator to conduct the study according to applicable guidelines and regulations.  The protocol or 
synopsis, study objectives, efficacy and safety variables and study procedures will be reviewed.   
The Sponsor will verify the investigator’s understanding of roles and responsibilities via the review of the 
obligations set forth by the statement of the investigator (investigator agreement).  Discussion of previous 
clinical experience, expertise in therapeutic areas, education and training qualifications (i.e., board 
certification in Obstetrics & Gynecology or equivalent), facility functions and staff resourcing and 
capabilities, and adequate pool of potential subjects from which to recruit will be reviewed to determine 
if the investigator and site are qualified to conduct the study.  
21.2 Financial Disclosure 
All Investigators must provide the Sponsor with documentation of financial interest related to MicroCube. 
Investigators must complete and provide Financial Disclosure in compliance with 21CFR 812.43 (c) (5) to 
the Sponsor during the approval process of the site and maintain this documentation throughout the 
study and for 1 year following completion of the study. 
21.3 Institutional Review Board Protocol and Informed Consent Approvals 
A sample ICF will be provided for the study investigator(s) to prepare for use at his/her site prior to 
participation in the study.  The written ICFs should be prepared in the language(s) of the potential patient 
population.  The ICFs that are used should be in accordance with the current guidelines as outlined by the 
21CFR Part 50, Good Clinical Practices (GCP) guidelines. 
The study Sponsor and reviewing IRB must first approve the language and the content within the 
Informed Consent form that is to be used by each study site.  A copy of the proposed ICF, other written 
patient information and any proposed advertising material must be submitted to the IRB for written 
approval. A copy of the written IRB approval of the protocol and Informed Consent form must be received 
by the study Sponsor before recruitment and enrollment of patients into the study.  The written approval 
must identify the study, protocol version, and the date of approval.  The Investigational site must submit 
to and, where necessary, obtain approval from, the IRB for all subsequent protocol amendments and 
changes to the ICF prior to implementation.  
The Investigator will be responsible for obtaining annual IRB approval and renewal throughout the 
duration of the study.  The Investigator and site personnel must forward copies to the Sponsor of all 

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required correspondence with the IRB, including the annual and continuing review reports and IRB 
continuance of approval.  Copies of such correspondence should be filed in the site study files. 
Additionally, the investigator will provide an IRB membership list or assurance number to the Sponsor 
annually. 
21.4 Protocol Amendments 
This protocol will only be altered by written amendments from the study Sponsor.  All significant protocol 
changes must receive written approval from appropriate Sponsor personnel, FDA (as appropriate) and 
from the IRB prior to implementation at the study site.  Upon IRB approval, the protocol amendment(s) 
will be distributed to all site study personnel and training will be performed as appropriate. 
21.5 Confidentiality 
All information and data sent to Sponsor, and its authorized representatives, concerning patients or their 
participation in this study will be considered confidential. All data used in the analysis and reporting of 
this evaluation will be used in a manner without identifiable reference to the patient. 
21.6 Study Administration 
21.6.1 Pre-Study Documentation Requirements 
Prior to initiation of screening and recruitment activities at any clinical site, the following documents must 
be provided to the Sponsor: 
x 
A signed and dated Investigator Agreement 
x 
A copy of the IRB approval letter of the protocol, Informed Consent and subject-facing 
documents/materials (e.g., questionnaires, PBLAC diary, etc.) 
x 
A copy of the IRB approved Informed Consent Form 
x 
Copy(ies) of the current signed and dated Curriculum Vitae of the Investigator (PI) and sub-
investigators (Sub-I) 
x 
A signed and dated Financial Disclosure Form 
x 
Approval of contract and budget 
x 
Copy(ies) of the current medical license(s) of the Investigator (PI) and sub-investigators (Sub-
I) 
21.6.2 General Investigator Responsibilities 
In order to ensure that the protocol is conducted in compliance to applicable regulations, each site 
Investigator must: 
x 
Conduct the study in accordance with the current revision of the regulations and guidelines 
of FDA (Protection of Human Patients (Informed Consent) (21 CFR Part 50), Financial 
Disclosure by Clinical Investigators (21 CFR Part 54), Institutional Review Boards (21 CFR Part 
56), Investigational Device Exemptions [(21 CFR Part 812), the Declaration of Helsinki, the 
privacy requirements of the Health Information Portability and Accountability Act (HIPAA)], 
ICH Good Clinical Practice and ISO 14155. 
x 
Assure that the study is not commenced until IRB approval has been obtained. 
x 
Complete all study related documents promptly. 

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x 
Agree to participate in an appropriate training program prior to first patient enrolled and as 
required by the Sponsor throughout the conduct of the study. 
x 
Sign and adhere to the Investigator Agreement / Financial Disclosure Form. 
x 
Assure that informed consent is obtained from each patient using the IRB-approved ICF. 
Informed consent must be obtained before conducting any study-specific tests or 
procedures (including activities to determine patient eligibility for the study) and without 
any coercion of or undue influence of patients to participate.  
x 
Ensure adverse events are reported within the guidelines provided in this protocol. 
x 
Provide all required data and agree to source document verification of study data with 
patient’s medical records. Allow study Sponsor staff and its authorized representatives to 
inspect and copy any documents pertaining to this clinical study. 
x 
Adhere to any institutional clinical care guidelines or protocols. 
x 
Comply with all required elements of this protocol (e.g., perform testing and follow-up as 
specified, especially during personnel transitions).  
21.7 Record Retention 
21.7.1 Health Insurance Portability and Accountability Act of 1996 
The Investigator agrees to comply with all applicable federal, state, and local laws and regulations relating 
to the privacy of patients’ health information, including, but not limited to, the Standards for Individually 
Identifiable Health Information, 45 CFR Parts 160 and 164 (the Health Insurance Portability and 
Accountability Act of 1996 privacy regulation). The Investigator shall ensure that study patients authorize 
the use and disclosure of protected health information in accordance with the privacy regulations of the 
Health Insurance Portability and Accountability Act. 
 
The Investigator agrees to maintain all essential study documents and source documentation, in original 
format, that support the data collected on the study patients in compliance with the ICH/GCP guidelines 
(the Investigator’s File, including signed Informed Consent forms and patient-related materials) in a 
location that is secure and to which access can be gained if required.  
 
Documents must be retained for at least two years after (1) study completion and FDA or other regulatory 
marketing approval, or (2) the study has been terminated by the Sponsor. These documents will be 
retained for a longer period of time by agreement with the Sponsor or in compliance with other site-
specific or local regulatory requirements. When these documents no longer need to be maintained, it is 
the study Sponsor’s responsibility to inform the Investigator. The Investigator will take measures to 
ensure that these essential documents are not accidentally damaged or destroyed. If, for any reason, the 
Investigator withdraws responsibility for maintaining these essential documents, the Sponsor must be 
notified prior to any transfer of responsibility. Custody must be transferred to an individual who will 
assume responsibility.  The Sponsor must receive written notification of this custodial change and will 
then notify FDA.  
21.7.2 Criteria for Suspending/Terminating a Study Center 
If Sponsor, Investigator, or officials from regulatory agencies discover conditions arising during the study 
that indicate the study should be halted or that the study site should be closed, this action may be taken 
after appropriate consultation between Sponsor and Investigator. If the study is prematurely terminated 

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or suspended, the Principal Investigator will promptly inform the IRB and provide reason(s) for the 
termination or suspension. Conditions that may warrant termination of the study include, but are not 
limited to: 
x 
Discovery of an unexpected, serious, or unacceptable risk to potential subjects or to the Patients 
already enrolled in the study. 
x 
Submission of knowingly false information from the research facility to Sponsor, study monitor, 
or regulatory agencies.  
x 
Failure of the Investigator to comply with GCP (e.g., ICH guidelines, regulatory agency guidelines) 
x 
Insufficient adherence to protocol requirements or unacceptable high rate of missing, erroneous, 
or improperly collected data.  
x 
A decision from Sponsor to suspend or discontinue testing, evaluation or development of the 
product. 
x 
Failure of the Investigator to enroll patients into the study at an acceptable rate. 
Subjects whose participation is prematurely discontinued as a result of trial termination or suspension 
should be followed in accordance with the standard of care for those that have undergone endometrial 
ablation.  
21.8 Publication Policy 
The data and results from the study are the sole property of the Sponsor.  The Sponsor retains all rights to 
publish its data.  The clinical investigation will be registered, and the description and results of the clinical 
investigation will also be made available in a publicly accessible database such as https://ClinicalTrials.gov. 
 
 

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representative of MicroCube, LLC.  Hardcopies for reference only. 
22 REFERENCES 
1. Fisher BR. FDA Letter to Endometrial Ablation Industry About Objective Performance Criteria, 
October 29, 2015. 
2. Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. 
British journal of obstetrics and gynaecology. 1990;97(8):734-739. 
3. Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact 
Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Current 
medical research and opinion, 2010;26(12):2745-2755. 
4. Laberge P, Garza-Leal J, Fortin C, Sabbah R, Fulop T, Pásztor N, Bacsko G. One-Year Follow-Up 
Results of a Multicenter, Single-Arm, Objective Performance Criteria-Controlled International 
Clinical Study of the Safety and Efficacy of the Minerva Endometrial Ablation System. J Minim 
Invasive Gynecol. 2015 Nov-Dec;22(7):1169-77. 
5. Levie MD, Chudnoff SG.  A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and 
Effectiveness of the AEGEA Vapor Endometrial Ablation System. J Minim Invasive Gynecol. 2018 
Jul 20.pii: S1553-4650(18)30360-1. 
6. US Department of Health and Human Services Food and Drug Administration, Adaptive Designs 
for Medical Device Clinical Studies Guidance for Industry and Food and Drug Administration Staff. 
July 27, 2016. 
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocum
ents/ucm446729.pdf 
7. Graham et al. (2007).  How Many Imputations are Really Needed?  Some Practical Clarifications 
of Multiple Imputation Theory.  Pre Sci, 8:206-213. 
8. Summary of Safety and Effectiveness Data for AEGEA Vapor System™, Premarket Approval 
Application (PMA) Number: P160047; Date of FDA Notice of Approval: June 14, 2017 
9. Summary of Safety and Effectiveness Data for Her Option™ Uterine Cryoblation Therapy™ 
System; Premarket Approval Application (PMA) Number: P000032; Date of FDA Notice of 
Approval April 20, 2001 
10. Summary of Safety and Effectiveness Data for Hydro ThermAblator® Endometrial Ablation 
System; Premarket Approval Application (PMA) Number: P000040; Date of FDA Notice of 
Approval: April 20, 2001 
11. Summary of Safety and Effectiveness Data for Minerva™ Endometrial Ablation System; 
Premarket Approval Application (PMA) Number: P140013; Date of FDA Notice of Approval: July 
27, 2015 
12. Summary of Safety and Effectiveness Data for NovaSure Impedance Controlled Endometrial 
Ablation System; Premarket Approval Application (PMA) Number: P010013; Date of FDA Notice 
of Approval: September 28, 2001 
13. Summary of Safety and Effectiveness Data for Microwave Endometrial Ablation (MEA) System; 
Premarket Approval Application (PMA) Number: P02003l; Date of FDA Notice of Approval: 
September 23, 2003 
14. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic 
(Guidance for Industry, Investigators, and Institutional Review Boards), March 2020 
15. FDA Guidance Statistical Considerations for Clinical Trials During the COVID-19 Public Health 
Emergency (June 2020) 
 
 
 

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23 SCHEDULE OF EVENTS 
 
Table 23-1:  Schedule of Events 
       
          Assessments 2                            
 
                      Validity Windows 
Screening / 
Baseline 
Procedure/ 
Discharge 
SOC 24-
hour 
contact 
Week 2 
Month 3 
Month 6 
Month 12 
Months 
24 & 36 
Various 3 
Day 0 
18-48 
hours  
± 7 days 
± 2 weeks 
± 2 weeks 
± 4 weeks 
± 8 weeks 
Informed Consent4  
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical and surgical history 
(including documented history of 
excessive menstrual bleeding) 
X 
 
 
 
 
 
 
 
Physical examination5 
X 
 
 
 
 
 
 
 
Pap-Smear6 
X 
 
 
 
 
 
 
 
Endometrial biopsy7  
X 
 
 
 
 
 
 
 
Transvaginal ultrasound/ 
Sonohysterography 
/hysteroscopy8 
X 
 
 
 
 
 
 
 
Vital Signs9 
 
X 
 
 
 
 
 
 
Complete Blood Count 
X 
 
 
 
 
 
 
 
Serum FSH 
X 
 
 
 
 
 
 
 
Urine Pregnancy10,11  
X 
X 
 
 
 
 
 
 
Minitouch Procedure 
 
X 
 
 
 
 
 
 
Con. Medications/ Treatments12  
X 
X 
X 
X 
X 
X 
X 
X 
 
2 If a patient terminates from the study during a visit, site will attempt to complete all assessments, and review Early 
Termination section requirements for additional testing. 
3 See Section 12.2 for screening validity windows.  Reassess dates of all study requirements prior to procedure to ensure that 
none are out of window. 
4 The informed consent process and signatures must precede any study-specific test or medication change. 
5 PE at Baseline includes pelvic and abdominal exam, height, weight, BMI.  Note height, weight, and BMI are required only at 
screening.   
6 Results from previous pap-smear may be used if done within 12 months of treatment. 
7 Results from the endometrial biopsy may be obtained from a prior biopsy result if done within 12 months of treatment.   
8 At least one gynecological diagnostic test is required. Measure uterine sounding depth, cervix length and cavity length.  
9 Vital signs to include temperature, pulse, respiratory rate and blood pressure after at least 5 minutes at rest in the sitting or 
supine position.   
10 Pregnancy test must be negative during screening and on day of procedure prior to procedure initiation.  Also, if study 
patient becomes amenorrheic at any time post-procedure, a urine pregnancy test should be administered. 
11 Conduct urine pregnancy tests as needed during follow-up; conduct STD tests as needed. 
12 η͵
months prior to enrollment and must remain on the same hormonal regimen through the 12-month follow-up visit. 

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Table 23-1:  Schedule of Events 
   Assessments 2          
    Validity Windows 
Screening / 
Baseline 
Procedure/ 
Discharge 
SOC 24-
hour 
contact 
Week 2 
Month 3 
Month 6 
Month 12 
Months 
24 & 36 
Various 3 
Day 0 
18-48 
hours  
± 7 days 
± 2 weeks 
± 2 weeks 
± 4 weeks 
± 8 weeks 
Patient PBLAC Training13  
X 
X 
Screening PBLAC14 
X 
Distribute PBLAC Diary and Product15  
X 
X 
X 
X 
X 
PBLAC Diary Collection 
X 
X 
X 
X 
Final Eligibility Assessment16 
X 
Menorrhagia Impact Questionnaire  
X 
X 
X 
X 
X 
Dysmenorrhea-related pain 
X 
X 
X 
X 
X 
Procedure-related pelvic pain17  
X 
X 
Patient Global Evaluation (PGE)  
X 
X 
X 
X 
Investigator Global Evaluation (IGE)  
X 
X 
X 
X 
AE / SAE / UADE18  
X 
X  
X 
X 
X 
X 
X 
 PBLAC training will be provided.  Study staff will review PBLAC diary instructions with patient during screening and 
discharge.  Additional refresher training may be conducted as needed through the 12-month follow-up visit.  
 PBLAC: 1 month of Screening/Baseline PBLAC Patient diary data is required and meet eligibility requirements. 
 PBLAC diaries will be collected/reviewed at each follow-up visit (except the 2-week follow-up visit) and a new one 
distributed.  In between visits, participants should return their diaries (in person or mail) every month upon completion.  
Scanned or photos of diaries are permitted to be submitted monthly, however, the original diaries must still be submitted to 
the site and retained in the study records as source documents.   
16 Eligibility criteria will be assessed at baseline and reconfirmed prior to procedure initiation.  Only patients who meet all 
eligibility criteria at that time will be included.
17 Pelvic pain (utilizing the NRS) will be evaluated BEFORE (prior to administration of procedure meds) and AFTER the 
procedure at discharge and during the SOC 24-hour telephone contact).
18 AE / UADE / SAE collection starts after subject is enrolled (on the day of the Minitouch procedure). 

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MicroCube, LLC. 
 
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MicroCube, LLC. 
 
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representative of MicroCube, LLC.  Hardcopies for reference only. 
ATTACHMENT B:  SAMPLE MENORRHAGIA IMPACT QUESTIONNAIRE (MIQ) 
MIQ concept  
MIQ item 
 
Response scale 
Perception of amount of blood 
loss 
MIQ 1  
‘During your most recent menstrual period, your 
blood loss was’: 
ප 
1. Light  
ප 
2. Moderate  
ප 
3. Heavy  
ප 
4. Very Heavy 
Limitations in work outside or 
inside the home 
 
MIQ 2  
‘During your most recent menstrual period, how 
much did your bleeding limit you in your work 
outside or inside the home?’ 
ප 
1. Not At All  
ප 
2. Slightly  
ප 
3. Moderately  
ප 
4. Quite A Bit  
ප 
5. Extremely 
Limitations in physical activities 
 
MIQ 3  
‘During your most recent menstrual period, how 
much did your bleeding limit you in your physical 
activities?’ 
ප 
1. Not At All  
ප 
2. Slightly  
ප 
3. Moderately  
ප 
4. Quite A Bit  
ප 
5. Extremely 
Limitations in social or leisure 
activities 
 
MIQ 4  
‘During your most recent menstrual period, how 
much did your bleeding limit you in your social 
or leisure activities?’ 
ප 
1. Not At All  
ප 
2. Slightly  
ප 
3. Moderately  
ප 
4. Quite A Bit  
ප 
5. Extremely 
Global assessment of change in 
blood loss 
 
MIQ 6/6a/6b  
Compared to your previous menstrual period, 
would you say your blood loss during this period 
was’: 
ප 
0. About the same 
 
1. Better (7-item scale): 
ප 
1. Almost the same, hardly better at all 
ප 
2. A little better 
ප 
3. Somewhat better 
ප 
4. An average amount better 
ප 
5. A good deal better 
ප 
6. A great deal better 
ප 
7. A very great deal better 
 
2. Worse (7-item scale): 
ප 
1. Almost the same, hardly worse at all 
ප 
2. A little worse 
ප 
3. Somewhat worse 
ප 
4. An average amount worse 
ප 
5. A good deal worse 
ප 
6. A great deal worse 
ප 
7. A very great deal worse 
Meaningfulness of perceived 
change in blood loss 
MIQ 6c  
‘Was this a meaningful or important change for 
you?’ 
ප 
0. No  
ප 
1. Yes 
*MIQ1:  If none of the choices are appropriate, subject should specify blood loss as ප none or ප spotting. 
**MIQ6/6a/6b:  To be completed at the follow-up visits (not required for Screening/Baseline).  Also, the perception of 
amount of blood loss for the most recent menstrual period should be compared to the perception of amount of blood 
loss assessed at Screening/Baseline. 
 

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ATTACHMENT C:  SAMPLE NUMERICAL RATING SCALE (NRS) FOR DYSMENORRHEA-
RELATED PAIN AND PROCEDURE-RELATED PELVIC PAIN 
 
 
Numerical Rating Scale (NRS) for Dysmenorrhea-related Pain 
 
On a scale of 0 to 10, with 0 being no pain and 10 being the worst pain possible, please mark the 
appropriate box that best describes your menstrual pain. 
 
පϬ 
පϭ 
පϮ 
පϯ 
පϰ 
පϱ 
පϲ 
පϳ 
පϴ 
පϵ 
පϭϬ 
No 
 
 
 
          Moderate  
 
 
 
Worst 
Pain 
 
 
 
              Pain 
 
 
 
 
 Pain 
 
 
 
 
 
 
 
 
 
              Possible 
 
 
 
Numerical Rating Scale (NRS) for Procedure-related Pain 
 
On a scale of 0 to 10, with 0 being no pain and 10 being the worst pain possible, please rate your 
procedure-related pain by marking the appropriate box that best describes your pain NOW. 
 
පϬ 
පϭ 
පϮ 
පϯ 
පϰ 
පϱ 
පϲ 
පϳ 
පϴ 
පϵ 
පϭϬ 
No 
 
 
 
          Moderate  
 
 
 
Worst 
Pain 
 
 
 
              Pain 
 
 
 
 
 Pain 
 
 
 
 
 
 
 
 
  
 
              Possible 
 
 
 
 
 

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ATTACHMENT D:  SAMPLE RATING SCALE FOR PATIENT AND USER (INVESTIGATOR) 
GLOBAL EVALUATION OF SATISFACTION WITH THE STUDY TREATMENT 
 
Patient Global Evaluation (PGE) 
Are you satisfied with the treatment you received for menorrhagia? 
ප   Very Satisfied 
 
ප   Satisfied 
ප   Not Sure  
 
 
ප   Dissatisfied   
ප   Very Dissatisfied 
How would you describe your menstrual status? 
ප   No Bleeding (Amenorrhea) 
 
ප   Spotting 
 
 
ප   Light Bleeding (Hypomenorrhea) 
ප   Medium or Normal Bleeding (Eumenorrhea)   
ප   High or Heavy Bleeding (Menorrhagia) 
Would you recommend this procedure to your friends? 
ප   Yes 
ප   No 
 
Investigator Global Evaluation (IGE) 
Are you satisfied with the treatment this patient received for menorrhagia?  
ප   Very Satisfied 
 
ප   Satisfied 
ප   Not Sure  
 
 
ප   Dissatisfied   
ප   Very Dissatisfied 
 
How would you describe the patient’s menstrual status?   
ප   No Bleeding (Amenorrhea) 
 
ප   Spotting 
 
 
ප   Light Bleeding (Hypomenorrhea) 
ප   Medium or Normal Bleeding (Eumenorrhea)   
ප   High or Heavy Bleeding (Menorrhagia)