RAFA Trial: Radiofrequency Ablation of Adenomyosis
Phase: NA
Conditions: Adenomyosis
Sponsor: University of Texas Southwestern Medical Center

STUDY PROTOCOL 
 
 
 
Official title:  RAFA Trial: Radiofrequency Ablation of 
Adenomyosis  
NCT number: NCT05130190 
IRB Approved date: 04-09-22 

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Protocol for the RAFA 
Trial: Radiofrequency 
Ablation of Adenomyosis 
 
 
 
UT Southwestern Medical Center 
PI: Kimberly Kho MD, MPH 
Department of Obstetrics and Gynecology 
 
 
Version Date: April 1, 2022 
 
 
 
 
 

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Table of Contents 
Background and Purpose .....................................................................................................3 
Experimental Procedures.....................................................................................................4 
Endpoints .............................................................................................................................4 
Sample Size ..........................................................................................................................4 
Number of Sites ....................................................................................................................4 
Design ..................................................................................................................................5 
A. Screening...................................................................................................................5 
B. Blinding .....................................................................................................................5 
C. Randomization ..........................................................................................................5 
D.    Baseline measurements .............................................................................................5 
E. Exposure assignments ...............................................................................................5 
F. Follow-up ..................................................................................................................5 
Subjects ................................................................................................................................5 
A. Selection Criteria ......................................................................................................5 
B. Identification .............................................................................................................6 
C. Informed Consent ......................................................................................................6 
D.    Enrollment Timeline ..................................................................................................7 
E. Treatment ..................................................................................................................7 
F. Subject Compliance ..................................................................................................7 
G.    Subject Discontinuation or Withdrawal ....................................................................8 
H.   Compensation and Costs for Study Participation ......................................................8 
I.     Contact for Scheduling ..............................................................................................8 
J. 
Visit Schedule ............................................................................................................8 
Study Device and Procedure ................................................................................................9 
Device Training .................................................................................................................10 
Risk Assessment .................................................................................................................10 
Benefits ...............................................................................................................................12 
Study Adverse Events .........................................................................................................12 
A. Definitions ...............................................................................................................12 
B. Investigator Records ...............................................................................................12 
C. Investigator Reports ................................................................................................12 
Confidentiality....................................................................................................................13 
Documentation ...................................................................................................................13 
A. Investigator Responsibility......................................................................................13 
Quality Assurance:.............................................................................................................14 
A. Data Quality Assurance ..........................................................................................14 
B. Monitoring ..............................................................................................................14 
C. Data Management ...................................................................................................14 
After monitoring of the data is complete, data will be entered into the database by a 
third-party data manager. ..............................................................................................14 
Data Analysis .....................................................................................................................14 
Personnel Responsibilities .................................................................................................14 
Return of Unused Inventory ...............................................................................................14 

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References ..........................................................................................................................14 
Pathology ...........................................................................................................................16 
Gross Uterine Pathology Evaluation .............................................................................21 
   TTC (Triphenyltetrazolium Chloride) Staining protocol for Macroscopic Tissue 
Viability Assessment........................................................................................................29 
Principal .........................................................................................................................29 
Specimen Requirements ..................................................................................................29 
Materials ........................................................................................................................29 
Stain Preparation ...........................................................................................................29 
Procedure .......................................................................................................................30 
Results ............................................................................................................................30 
Microscopic Uterine Pathology Evaluation ...................................................................32 
 
 
Background and Purpose 
Adenomyosis is a benign but progressing medical condition characterized by the growth 
of endometrial cells within the uterine wall and is prevalent in 20-35% of women in the 
general population1. The endometrial cells misplaced in the uterine wall are completely 
functional and will bleed during every menstrual cycle[2] thus causing pelvic pain and 
discomfort. Hormonal factors, parity, age, and uterine abrasion are thought to influence the 
development of adenomyosis. Patients with adenomyosis are most often between the ages 
of 35 and 50[3] and commonly report dysmenorrhea, menorrhagia, dyspareunia, chronic 
pelvic pain and infertility.  
Adenomyosis can be focal or diffuse and is often associated with other uterine conditions 
such as fibroids, endometriosis, and/or endometrial polyps. Focal adenomyomas may be 
mistaken for a uterine fibroid during imaging. Upon imaging or surgical removal, the uterus 
generally appears larger than normal, particularly when the disease is diffuse where it is 
described as “bulky” or “heavy”.[4]  
The junctional zone, also called the “inner myometrium” is thought to play a role in the 
development and diagnosis of adenomyosis. Thickening, enlargement, invasion, or 
disruption of this junctional zone are “markers” for adenomyosis during magnetic 
resonance imaging (MRI) or transvaginal ultrasound (TVUS). In addition to this 
thickening, findings such as anterior/posterior wall asymmetry, echogenic linear striations, 
or myometrial cysts may be present. [4][5][6]  Doppler ultrasound can also be used to look for 
circumferential blood vessels that are characteristic of fibroids vs adenomyomas that have 
vessels found within the lesion. [7][8] A definitive diagnosis for adenomyosis is obtained 
through the examination of uterine tissue following a uterine biopsy or hysterectomy. 
Under the microscope, the pathologist looks for clusters of endometrial tissue within the 
myometrium and if the depth of invasion is between 2.5 and 8mm, adenomyosis is 
confirmed. [4] 
The definitive treatment for adenomyosis is hysterectomy though patients may respond to 
the administration of non-steroidal anti-inflammatory drugs for pain relief.  Reproductive 
hormones and hormone modulators such as the Mirena IUD [9] may help to reduce 
menstrual pain and bleeding. Other hormonal treatments that have been used with some 

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level of pain relief and disease regression are oral contraceptives, progestins, and GnRH 
agonists.   
The surgical options for treatment are generally classified as uterine-sparing or non-uterine 
sparing. The non-uterine-sparing approach is hysterectomy and, as stated above, is the only 
definitive treatment for adenomyosis.  Uterine-sparing procedures such as uterine artery 
embolization (UAE) have been used to provide some improvement in menstrual bleeding 
and pain. However, 26% of women undergoing UAE later require a hysterectomy. [4] Other 
uterine-sparing surgical options include myometrial or adenoma resection, myometrial 
electrocoagulation, endometrial ablation, myometrial reduction, or magnetic-resonance 
focused ultrasound. [4] 
One proposed method of focal ablation for the treatment of adenomyomas has been used 
successfully in the treatment of uterine fibroids, providing long term relief of fibroid-
related symptoms: laparoscopic radiofrequency ablation, or LAP-RFA. [10][11]In the process 
of enrolling subjects in an FDA-regulated trial, investigators often encountered women 
who presented with adenomyomas or diffuse adenomyosis and who, based on exclusion 
criteria, were not eligible to be treated in the trial. [Personal communication] Several 
surgeons 
proposed 
LAP-RFA 
as 
a 
viable 
method 
of 
treating 
focal 
adenomyosis/adenomyomas. The objective of this study is to observe the effects of RFA 
on adenomyosis through the pathological analysis of the treated tissue that has been 
removed during a planned hysterectomy.  
 
Experimental Procedures 
 
At the time of the subject’s trans-abdominal or laparoscopic hysterectomy, the ProVu 
System will be used to apply RF treatment to one or two adenomas, focal areas of 
adenomyosis, or diffuse adenomyosis. Women who require a hysterectomy do not 
normally undergo this procedure.    
 
Endpoints  
The endpoint of this study is the pathological analysis of the treated tissue after application 
of RF treatment. 
 
Sample Size 
Up to twenty (20) subjects will be expected to complete this study. We expect that 
enrollment of up to 40 subjects may be necessary due to the requirement for a baseline 
MRI to verify, locate and “map” the adenomyosis/adenomyomas.  
 
Number of Sites 
One site will participate. Site will be required to receive study approval from the 
Institutional Review Board (IRB) prior to study inception.  Study enrollment will not begin 
until IRB approval is obtained.   
 

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Design 
This is an open-label, prospective, non-randomized, non-controlled study designed to 
obtain pathology results from the treatment of adenomyomas and/or adenomyosis using a 
system designed for the ablation soft tissue including symptomatic fibroids.    
A. 
Screening 
The standard pre-screening for hysterectomy eligibility is expected to be completed 
before patients are referred to the investigator. Upon referral and following consent, 
the investigator will review the subject’s files and images to determine if the initial 
inclusion/exclusion criteria have been met.     
B. 
Blinding  
Blinding will not be appropriate for this study. The subjects and investigators will be 
informed regarding the use of the system. 
C. 
Randomization 
Subjects will not be randomized.  
D. 
Baseline measurements 
After the initial screening of the patient’s records including imaging results, both a pre-
operative endometrial biopsy (standard of care) and Magnetic Resonance Imaging 
(MRI) will be performed (if not previously performed within 12 months) to verify 
enrollment criteria and locate/measure the adenomyosis/adenomyomas.  
E. 
Exposure assignments 
The length of time that the subject will be exposed to the ProVu System is as follows: 
 
Period of exposure to the device 
Number of subjects exposed 
< 30 minutes 
< 20 
 
F. 
Follow-up 
Subjects will be followed for safety postoperatively for 6 +/- 2 weeks. The subject’s 
participation in this study ends at the conclusion of the postoperative visit.  
 
Subjects 
A. 
Selection Criteria 
The criteria listed below shall be used to determine if a participant is eligible for 
entry into the study. 
 
Inclusion Criteria:  Women who are/have  

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• planning to undergo an abdominal, laparoscopic, or robotic-assisted 
hysterectomy due to benign conditions, 
• uterus < 16 weeks gestational size if undergoing a laparoscopic or robotic 
procedure (no size limit for patients planning to undergo a transabdominal 
hysterectomy), 
• at least one area of focal or diffuse adenomyosis or adenomyomas that is/are 
contralateral to any fibroids as determined by MRI, 
• able to provide informed consent, 
• suitable candidates for surgery (have passed a standard pre-operative health 
assessment), 
• English speaking. 
 
Exclusion Criteria:  Women who: 
• require emergent hysterectomy or vaginal hysterectomy,  
• have a uterus > 16 weeks gestational size if undergoing  a laparoscopic or 
robotic procedure (no size limit for patients planning to undergo a 
transabdominal hysterectomy)  
• have fibroids in the proximity of the target adenomyosis (same side, similar 
location), 
• are not appropriate surgical candidates as determined during  pre-operative 
health assessment, 
• are unable or unwilling to undergo a hysterectomy, 
• are pregnant or lactating, 
• are under the age of 18 years, 
• 
have active pelvic inflammatory disease,  
• 
have a history of gynecologic malignancy  within the past 3 years, 
• 
are unable to give informed consent, or 
• 
have an implantable uterine or fallopian tube device for contraception 
• 
are not English speaking. 
 
If the subject has been found to have one or more exclusion criteria even after enrollment, 
the subject will be withdrawn from the study prior to the RF ablation procedure. 
B. 
Identification 
The investigator shall assign an identification code to each subject; all data forms 
and images shall identify the subject by this identification code only. 
C. 
Informed Consent 
If a subject meets the inclusion/exclusion criteria, the investigator will explain the 
conditions of the study. The informed consent documents shall be approved by the 
IRB prior to use. Informed consent shall be obtained under the conditions as 
follows: 
1. The Principal Investigator or a member of the clinical staff to whom the 
Principal Investigator may have delegated this responsibility, will 

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provide the subject with a thorough explanation of the study design, its 
procedures, expected benefits and potential risks, and all pertinent 
aspects relative to protection of subjects’ safety, wellbeing and 
confidentiality. During this process, the subject will be allowed to ask 
all the questions she may have and will receive answers to such 
questions to her satisfaction. The consenting process will be 
documented in the subject’s study file with a physician’s note.  
2. the subject shall have sufficient opportunity to consider participation in 
the study,  
3. informed consent shall be obtained without coercion or undue influence,  
4. informed consent shall be written in English, 
5. a subject will not be led to believe that she is waiving her rights as a 
subject. 
D. 
Enrollment Timeline 
Enrollment occurs when the subject successfully completes the pre-operative health 
assessment procedures, has met all inclusion/exclusion criteria, and has signed the 
informed consent document. Study participation ends when the subject has 
completed her hysterectomy and postoperative period (6 +/- 2 weeks) or if the 
subject withdraws or has been withdrawn from the study prior to her hysterectomy. 
E. 
Treatment  
1. All subjects will be under general anesthesia per institutional guidelines.  
2. Standard sterile preparation and operative technique will be used. 
3. Intraoperative ultrasound will be used to locate target areas of adenomyosis prior 
to treatment, measure the volume of tissue to be treated, and to guide the 
placement of the treatment probe. 
4. The ProVu treatment probe will be energized and RF energy delivered in a pre-
programmed, controlled method based on the predetermined size of the affected 
tissue. 
5. Information on all treated tissue regarding location, morphology, size, 
deployment, generator mode, treatment temperature, and treatment time will be 
documented. 
6. The treatment probe will be removed and the site assessed for hemostasis. 
7. All hysterectomies will be performed according to standard surgical practice. 
8. All tissue will be excised with minimal disruption at the time of surgery and will 
be sent to the hospital pathologist or a core laboratory for assessment.   
9. All subjects will exit the study at the time of the postoperative follow up.  
10. All other medical care shall be in accordance with accepted medical practice. 
F. 
Subject Compliance 
All subjects entering the study are expected to have agreed to a hysterectomy due 
to pre-existing conditions and to have passed a standard pre-operative health 
assessment.   

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G. 
Subject Discontinuation or Withdrawal 
The investigator may withdraw the subject at any time if it is in the subject’s best 
interest. Subjects may voluntarily withdraw from the study at any time without 
reason. The investigator shall complete a study exit case report form.  
H. 
Compensation and Costs for Study Participation 
Subjects will be offered compensation of $300 for their participation in the study. 
Subjects will not be required to pay for any of the study procedures or materials 
during the course of this study. The study grant will not cover non-medical costs or 
complications that are a result of the standard surgical procedure.  
I. 
Contact for Scheduling 
Phone contact for appointment reminders and/or mailed pre-operative instructions 
prior to surgery dates will be the primary methods of contact. 
J. 
Visit Schedule 
The initial screening will be conducted using patient records, prior imaging results, 
and visit notes. Once subjects have consented to be in the study, they will have an 
MRI from which the diagnosis of focal or diffuse adenomyosis/adenomyoma is 
confirmed and lesions are measured. All MRIs will be read by one central 
radiologist. An endometrial biopsy is standard of care and may have been 
performed prior to enrollment. (Refer to Table I.) 
 
 

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TABLE I: VISIT SCHEDULE: 
 
 
Screening/Enrollment 
Visit 
Surgery Day 
Follow Up 6 +/- 2 
weeks Post Op 
Pre-op Health Assessment 
Based on Medical Records, 
Review of Prior Imaging 
Results (TVUS and/or MRI)  
X 
 
 
Informed Consent 
X 
 
 
Magnetic Resonance 
Imaging (to verify and 
measure diffuse or focal 
adenomyosis/adenomyomas), 
if not performed within the 
last 12 months 
X 
 
 
Endometrial Biopsy (standard 
of care) within 12 months  
X 
 
 
Pregnancy Test (standard of 
care) within 24 hours 
X 
x 
 
Device Use at Surgery  
 
x 
 
Adverse Event Form  
 
x 
x 
Study Exit 
 
 
x 
 
Study Device and Procedure 
The ProVu™ System (Hologic, Inc., Boston, MA) is designed and cleared by the FDA as 
a treatment method for soft tissue, including the treatment of symptomatic uterine fibroids. 
After locating the general region of the target tissue, a laparoscopic ultrasound transducer 
is placed on the serosal surface of the uterus to identify the size, location, and number of 
focal adenomyosis (or adenomyomas). Under ultrasound guidance, the treatment probe 
(handpiece) is inserted through the serosal surface and into the target tissue. The electrode 
array containing multiple thermocouples is then deployed according to the size of the target 
tissue and the position is verified using the ultrasound transducer. Once correctly placed, 
the surgeon initiates ablation by pressing the foot pedal. Continuous temperature feedback 
is displayed on the generator screen. For safety purposes, dispersive pads are placed on the 
patient’s thighs to disperse electrical current. If the target tissue is irregular or large, the 
needle array is retracted and the probe repositioned within the same area under ultrasound 

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guidance. The ablation is repeated until the area of interest is ablated. Overlapping 
ablations may be required. At the conclusion of the final ablation, the surgeon retracts the 
array withdraws the probe through the serosal surface of the uterus while coagulating the 
track to avoid bleeding. Once hemostasis is confirmed and all target tissue has been treated, 
the surgeon proceeds with the planned hysterectomy and the tissue is examined by a 
pathologist to assess the ablation zones within the adenomyoma or focal adenomyosis.  
 
Device Training 
All investigators will have completed training on the ProVu system prior to enrollment in 
this study. 
 
Risk Assessment 
A. Standard surgical risks 
Participation in the study does not eliminate the standard risks of hysterectomy.  
These include, (but are not limited to), nausea, vomiting, pain, bleeding, infection, 
poor healing, hernia formation, temporary change in bowel or bladder function, 
formation of adhesions, air in tissue or abdominal cavity, bleeding at incision 
sites(s) or abdominal wall, vasovagal reactions, heart attack, fever, infection, and 
inflammation in the abdomen.  Unexpected reactions can occur from any drug or 
anesthetic that is administered.  Unintended injury may occur to other pelvic or 
abdominal structures such as fallopian tubes, ovaries, uterus, bladder, ureter, bowel, 
or large blood vessels.  Such injury may require immediate surgery or may require 
surgery at a later time.  Dangerous blood clots may form in the legs or lungs. 
Participation in this study is not expected to alter the likelihood of occurrence or 
severity of any of these standard surgical risks. 
 
B. Device risk 
A significant-risk (SR) device study is defined by the United States Food and Drug 
Administration (https://www.fda.gov/media/75459/download) as one that: 
• Is intended as an implant and presents a potential for serious risk to the health, 
safety, or welfare of a subject;  
• Is purported or represented to be for use supporting or sustaining human life 
and presents a potential for serious risk to the health, safety, or welfare of a 
subject;  
• Is for a use of substantial importance in diagnosing, curing, mitigating, or 
treating disease, or otherwise preventing impairment of human health and 
presents a potential for serious risk to the health, safety, or welfare of a subject;  
• or otherwise presents a potential for serious risk to the health, safety, or welfare 
of a subject. 
 
A Non-Significant Risk (NSR) device study is one that does not meet the definition 
for an SR device study. This study poses no significant risks to subjects due to the 
planned hysterectomy. Risks associated with the device include minimal bleeding 

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that is no greater than that experienced during pelvic surgery.  Bleeding can be 
easily identified and corrected during the hysterectomy. If bleeding is encountered, 
it will be managed and the hysterectomy would proceed as planned. The risk of 
infection from this device or procedure is not expected to be any greater than the 
risk of infection following a hysterectomy.   
 
Risks associated with the use of radiofrequency ablation in this study are minimal 
due to the laparoscopic or direct visualization technique utilized in this study. In 
addition, ultrasound is used to locate and observe regions within the uterus that are 
not easily visualized directly.  The dispersive electrodes on the ProVu System are 
designed to monitor temperature at three locations of dispersive pad and therefore 
risks of skin burns are minimized.  
 
C. Physical risks and discomforts.   
The subjects will undergo normal medical care in every respect except that 
additional pre-operative screening (MRI) will be provided and the ProVu System 
will be used immediately prior to the scheduled hysterectomy.  The use of the 
ProVu System will add approximately 30 minutes of anesthesia time.  The 
additional anesthesia time is not considered significant.  This study is considered to 
be non-significant risk (NSR) because the hysterectomy has been planned and only 
30 minutes of additional anesthesia time is required to complete the ablation 
procedures. 
 
D. Other risks-confidentiality 
Every effort will be made to maintain subject confidentiality.  Subjects will be 
identified primarily by their case report form (CRF) code in the records and 
databases kept by the company. All the CRFs in which study data are maintained 
will be coded to disguise any of the subjects’ personal information that is unrelated 
to the study. We cannot guarantee complete confidentiality as subject data may 
need to be made available to treating medical personnel, , Hologic, Inc. or other 
authorized outside agencies such as the United States Food and Drug 
Administration (FDA).  
 
E. Treatment and compensation for injury.  
If the subject is injured as a result of participating in the study, the subject will be 
treated appropriately until the resolution or stabilization of the injury.  The 
investigator will immediately notify  the manufacturer of the occurrence.  If it is 
determined that the ProVu System is responsible for the subject’s physical injury, 
the manufacturer may cover the cost of treatment for the injury. The manufacturer 
will not cover non-medical costs or indemnification other than may be required by 
law. Refer to the ProVu System “Instructions for Use” for all warnings and 
precautions.  

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Benefits 
This is a feasibility protocol for research into the effects of radiofrequency ablation on 
adenomyosis in women who are already planning to have a hysterectomy. Therefore, there 
is no expected direct benefit to the subjects enrolled in this study. Other women may benefit 
from the use of the ProVu System in the treatment of adenomyosis in the future. Society 
will benefit if it is established that this System design is appropriate for use in a larger 
population. 
 
Study Adverse Events 
A. 
Definitions 
An adverse event is any undesirable medical occurrence or untoward deviation in 
health away from baseline. An unanticipated adverse event is one that is not 
identified in nature, severity, or frequency in the current instructions for use and 
informed consent. A device related adverse event or adverse effect is one that is 
either definitely, probably, or possibly a result of device use. A Serious Adverse 
Event is any AE that is fatal, immediately life-threatening (i.e., presents an 
immediate risk of death at the time of the AE, not an AE that hypothetically might 
have caused death if it were more severe), requires or prolongs in-patient 
hospitalization, causes permanent or significant disability, requires medical or 
surgical intervention to prevent permanent sequelae, or any of the outcomes listed 
above. 
B. 
Investigator Records 
 
The investigator shall categorize adverse events according to the following scale: 
 
 
 
[   ] 1. Definitely device related 
 
 
[   ] 2. Probably device related 
 
 
[   ] 3. Possibly device related 
 
 
[   ] 4. Probably not device related 
 
 
[   ] 5. Definitely not device related 
C. 
Investigator Reports 
The investigator shall report all adverse events that are unanticipated and are device 
related to the manufacturer by telephone immediately upon becoming aware of 
them. A follow-up written report shall be emailed to the manufacturer within 24 
hours and shall include the following information: 
 
i. Nature of adverse effect 
ii. Statement as to why it is considered unanticipated 
iii. Statement as to the degree to which it is considered device related, and why 
iv. Results of any diagnostic tests that were performed 
v. Description of any treatment implemented 

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vi. Statement of subject’s current clinical status 
vii. Investigator’s signature and date 
 
 
The investigator shall supply a copy of the report for adverse events that are serious 
or unanticipated and device related to the reviewing IRB. 
 
 
The investigator shall continue to clinically monitor the adverse effect, with 
laboratory tests if appropriate, until it is resolved, stabilized or returns to baseline. 
 
Confidentiality 
Research records are marked by subject number and initials.  Subject research files, 
including signed consent forms, will be kept in locked cabinets at the study site.  All 
information provided to the Investigator by the manufacturer, or its designates, including 
non-clinical data, protocols, CRFs, and verbal and written information, will be kept strictly 
confidential and confined to the research staff involved in conducting the study. It is 
recognized that this information may be related in confidence to the IRB.  Subjects’ records 
will be made available to regulatory authorities as required. 
 
Documentation 
Accurate, complete and timely documentation is essential to the successful conduct of this 
study.  
A.  
Investigator Responsibility 
The investigator is responsible for maintaining the following documentation as updated 
and complete as possible at all times: 
 
1. Informed consents. 
2. Case report forms. 
3. Adverse effect reports to the manufacturer. 
4. Adverse effect reports to IRB. 
5. Photographs, videos, images, if any. 
6. Material control logs. 
7. Screening logs. 
8. IRB approval for protocol. 
9. IRB approval for informed consent. 
10. Final report to the IRB and manufacturer, in addition to any other reporting 
requirement that may be requested. 
11. Records of deviations, violations and amendments. 
12. Protocol (including all revisions). 
13. Regulatory Binder. 
14. Agreement Letter and Study Site Contract. 
15. All correspondence relating to study. 
 

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Quality Assurance: 
A.  
Data Quality Assurance 
Steps to be taken to assure the accuracy and reliability of data include review of 
protocol procedures with the investigator and associated personnel prior to the 
study. Case report forms will be reviewed for accuracy and completeness as 
compared with the source documents. 
B.  
Monitoring 
Monitoring will be performed according to Good Clinical Practices (GCP) 
guidelines established by the United States Food and Drug. A Contract Research 
Organization (CRO) may be used to monitor the study. Monitoring will be 
scheduled in accordance with recruitment/enrollment rates and site performance 
requirements. 
 
C.      Data Management 
After monitoring of the data is complete, data will be entered into the database by 
a third-party data manager. 
 
Data Analysis 
Data analysis will consist of the evaluation of the ProVu System performance relative to 
the proposed use, prescribed treatment, pathology results and adverse device effects.  
Descriptive statistics (including those derived from pathology results, see Appendices A-
C) will be provided as dictated per protocol. A full statistical analysis will not be 
appropriate considering the size and intent of this study.  
 
Personnel Responsibilities 
The investigator will assign a study coordinator to assist during the conduct of this study. 
There are no other required site personnel.   
 
Return of Unused Inventory 
All unused System handpieces shall be returned to the manufacturer.  Used electrodes will 
be disposed of according to hospital standards for biohazard materials. Any generators, 
cables, and other non-disposable parts that are donated for use during this study will be 
returned to the manufacturer at the conclusion of the study. 
 
 
References 
1.  https://en.wikipedia.org/wiki/Adenomyosis 
2. Gunther R, Walker C (2020). "Adenomyosis" StatPearls [Internet]. Treasure Island 
(FL): StatPearls Publishing; 2020 Jun 24.PMID 30969690. 

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3. Brosens I, Gordts S, Habiba M, Benagiano G (December 2015). "Uterine Cystic 
Adenomyosis: A Disease of Younger Women". J Pediatr Adolesc Gynecol. 28 (6): 
420–6. doi:10.1016/j.jpag.2014.05.008. PMID 26049940. 
4. Struble, Jennifer; Reid, Shannon; Bedaiwy, Mohamed A. (2016). "Adenomyosis: A 
Clinical Review of a Challenging Gynecologic Condition". Journal of Minimally 
Invasive 
Gynecology. 23 (2): 
164- 
185. doi:10.1016/j.jmig.2015.09.018. PMID 26427702. 
5.  Kepkep K, Tuncay YA, Göynümer G, Tutal E (2007). "Transvaginal sonography in the 
diagnosis of adenomyosis: which findings are most accurate?". Ultrasound Obstet 
Gynecol. 30 (3): 341–5. doi:10.1002/uog.3985. PMID 17659649. S2CID 26333703. 
6.  Sakhel K, Abuhamad A (May 2012). "Sonography of adenomyosis". J Ultrasound 
Med. 31 (5): 
805–
8. doi:10.7863/jum.2012.31.5.805. PMID 22535729. S2CID 37627898. 
7.  Dartmouth, Katherine (2014-08-01). "A systematic review with meta-analysis: the 
common sonographic characteristics of adenomyosis". Ultrasound. 22 (3): 148–
157. doi:10.1177/1742271X14528837. ISSN 1742-
271X. PMC 4760530. PMID 27433212. 
8.  Sharma, Kaveri (2015). "Role of 3D Ultrasound and Doppler in Differentiating 
Clinically Suspected Cases of Leiomyoma and Adenomyosis of Uterus". Journal of 
Clinical 
and 
Diagnostic 
Research. 9 (4): 
QC08–
12. doi:10.7860/jcdr/2015/12240.5846. PMC 4437118. PMID 26023602. 
9. Bragheto A.M.; et al. (2007). "Effectiveness of the levonorgestrel-releasing intrauterine 
system in the treatment of adenomyosis diagnosed and monitored by magnetic 
resonance 
imaging". Contraception. 76 (3): 
195–
9. doi:10.1016/j.contraception.2007.05.091. PMID 17707716. 
10. Berman JM, Guido RS, Garza Leal JG, et al. (2014). “Three-year outcome of the Halt 
trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.” 
J Minim Invasive Gynecol.21(5):767-774. PMID:  24613404 
11. Krämer B, Hahn M, Taran FA, Kraemer D, Isaacson KB, Brucker SY. Interim analysis 
of a randomized controlled trial comparing laparoscopic radiofrequency volumetric 
thermal ablation of uterine fibroids with laparoscopic myomectomy. Int J Gynaecol 
Obstet. 2016 May;133(2):206-11. PMID: 26892690 ClinicalTrials.gov Identifier: 
NCT01750008 
 
 

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Pathology 
The hospital pathologist will be responsible for issuing separate standard of care anatomic 
pathology reports for subsequent patient care and that will not be incorporated into this 
study. As tissues required for patient care will be separately preserved for evaluation by 
the hospital pathologist, any tissues utilized / submitted in this study will be for 
investigational use only. 
 
The intact uteri will be received fresh in pathology within four hours of completion of the 
in vivo hyperthermic treatment and two hours of completion of the hysterectomy. Care 
needs to be taken to ensure that the specimen surfaces do not dry and are not overly 
hydrated in the operating room, during hyperthermic treatment or during transportation to 
the pathology laboratory.  
 
The uteri will be received labeled with the patient’s name, hospital number, study 
number, specimen number, test article and test system. Upon receipt in pathology, the 
specimen will be accessioned in preparation for evaluation. The gross tissue evaluation 
findings will be recorded on the Gross Pathology Case Report Form (Appendix A). 
 
The anterior and posterior uterine surfaces with attached cervix and adnexal organs 
(when present) will be digitally photographed as an intact organ block or bivalved. All 
orienting photographs will contain a scale and specimen identifier.  
 
The uterus will be weighed and measured. After removing the adnexa (if present), the 
uterus with attached cervix will be anatomically oriented. Using different marking inks 
for correlation with the marking sutures, the individually ablated area will be focally 
inked for identification during the sectioning process. A midline anterior black ink strip 
will be used to mark the anterior serosal side of each tissue slice. 
 
The uterus will then be serially sectioned in the sagittal plane into approximately 5-8mm 
macroscopic tissue slices (Figure 1).  An attempt will be made to adjust the sectioning so 
that the cuts pass though the center of each thermal lesion in the sagittal plane. 
 
 

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Figure 1.  Serial uterine sectioning through the treated areas (grey circles). 
 
 
The tissue slices will be serially laid out and digitally photographed on both sides (Figure 
2). All orienting photographs will contain a scale and specimen identifier. 
                  
                                  
 
Figure 2.  Serial unstained uterine tissue sections through the treated areas (grey circles). 
                      Variable hyperemic rings demarcate the ablation region zones.  
                      The number of slices thought a particular tissue zone will vary with its size. 
                                      
The uterus will be examined for pre-existing intrauterine lesions. The number of 
leiomyomata, adenomyosis-like lesions and/or other gross lesions will be recorded. The 
number, size range (diameter) and location of the lesions will be recorded. Untreated 
lesions numbering greater than four (4) will be recorded as “multiple.” Treated lesions 
must be identified as shown above in the grey circles. 
 
In appropriately labeled plastic container(s), the uterine tissue slices will be 
macroscopically triphenyltetrazolium chloride (TTC) stained to assess for regions of 

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thermal enzyme inactivation (viability stain). The staining protocol is outlined in Appendix 
B.  The thermal-treated regions will be assessed with TTC staining within four hours after 
completion of the thermal treatment. The presence of a pink-maroon color change in the 
tissue will be interpreted as having functional enzyme activity (diaphoreses / NADH; TTC-
positive). The absence of a color change and preservation of native tissue coloration will 
be interpreted as having non-functional enzyme activity (TTC-negative). 
 
The TTC-stained tissue slices will be digitally photographed following fixation of the TTC-
stain with 10% neutral buffered formalin. The macroscopic TTC-stained tissue slices will 
be fixed in 10% neutral buffered formalin for at least 15 minutes but less than 24 hours 
prior to measurements and photography. 
 
                              
 
 
Figure 3.  Serial TTC-stained uterine tissue sections through the treated tissue (circles). 
White zones represent TTC-negative ablation regions involving the treated zones 
and to varying extents the adjacent tissues. 
 
The three-dimensional size (cranial/caudal, anterior/posterior and right/left axis), type 
(submucosal, intramural, or subserosal) and location (fundus, right cornu, left cornu, 
anterior corpus, posterior corpus, right corpus, left corpus, anterior lower segment or 
posterior lower segment) of each treated area will be recorded. The closest distance of the 
treated zone to the uterine serosa and intrauterine cavity will be recorded. Measurements 
will be made with calipers to within ±0.1 mm. 
 
Using the TTC-stained tissue slices, the three-dimensional size of the devitalized TTC-
negative primary ablated region will be measured in the cranial/caudal, anterior/posterior 
and right/left axis. The location of the lesion within the adenomyosis will be documented 
(centered of eccentric). The approximate percentage of the target area treated by the ablated 
volume will be estimated. The closest distance between the TTC-negative primary thermal 
lesion and the uterine serosa and intrauterine cavity will be recorded.  Measurements will 
be made with calipers to within ±0.1 mm. 
 

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Representative tissue blocks from the central ablation zone section will be taken from the 
10% neutral buffered formalin fixed tissue. The submitted tissue blocks will be routinely 
processed and subsequently paraffin-embedding at the local Institution. The formalin-fixed 
/ paraffin-embedded blocks will be faced and five micron hematoxylin and eosin stained 
sections prepared for review. Under fixed blocks will require reprocessing prior to 
preparation of the hematoxylin and eosin-stained sections. One slide will be prepared per 
block and labeled with specimen, treated area, and location identifiers. 
 
As the tissue was treated on the same day as the hysterectomy (Day 0 specimen), the 
histological manifestations of cell injury (coagulative necrosis) will not be morphologically 
evident. While subtle thermal change can be seen in the treated tissue, a discreet boundary 
of devitalize versus viable tissue cannot be reliably ascertained. Therefore, the hematoxylin 
and eosin stained slides will be reviewed and a global brief microscopic summary prepared 
for each slide set. Microscopic measurements will not be made on the hematoxylin and 
eosin stained slides. Specific unique hematoxylin and eosin microscopic findings will be 
reported by location identifier, if present. 

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Appendix A – Gross Pathology Case Report Form 
 
 

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Gross Uterine 
Pathology Evaluation 
Hologic, Inc. 
Study/Protocol Number  
Subject ID 
Institution / Site Number:  
Uterus 
ID 
Number 
(Hosp. 
Number): 
Test Article: ProVu 
Test System: In Vivo Human Adenomyosis 
Specimen Type:  Human Uterus 
Surgery Date:                                  (DD/MMM/YYYY) 
Time of Receipt:                                        (HH:MM)        
Dissection Date:                              (DD/MMM/YYYY) 
 
1.  Digital Anterior/Posterior Photographs Prior to Dissection with 
Adnexa: 
      (include identifying tags and scale) 
□ 
 
Yes: 
 
Total 
Number 
____________ 
 
 □ 
 
No: 
 
 
Comment 
:_________________________________________ 
 
2.  Uterine Weight and Measurements: 
 
a.  Uterine weight without adnexa:            
______ grams  
 
b.  Uterine length (fundus to cervix):        
______ cm 
           Uterine thickness (anterior/posterior):   
______ cm 
           Uterine widths (right/left): 
 
Uterotubal / fundus region  
______ cm 
Mid corpus region       ______ cm 
 
 Lower segment region 
______ cm 
 
3.  Ovaries and Fallopian Tubes: 
a.  Right Ovary:  
 
□  Absent  
 
□ 
 
Present 
- 
Size: 
___ 
x 
___ 
x 
___ 
cm;  
          
Description:_____________________________________________________ 
 
b.  Right Fallopian Tube: 
 
□  Absent  
 
□  Present - Size: ___ x ___ x ___ cm;            
            
Description:_____________________________________________________ 
 
c.  Left Ovary:  
 
□  Absent  
 
□  Present - Size: ___ x ___ x ___ cm;  
            
Description:_____________________________________________________ 
 
d.  Left Fallopian Tube: 
 
□  Absent  
 
□  Present - Size: ___ x ___ x ___ cm;  

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Description:_____________________________________________________ 
 
4.  Other External Observation(s):    
      _______________________________________________________________ 
 
      _______________________________________________________________ 
      _______________________________________________________________ 
5.  Macroscopic Tissue Sectioning:                              
 
Using different marking inks for correlation with the marking sutures, 
the one to three individually ablated areas will be focally inked for 
identification during the sectioning process. A midline anterior black 
ink strip will be used to mark the anterior serosal side of each tissue 
slice.  The uterus will then be serially sectioned in the sagittal plane 
into approximately 5-8mm macroscopic tissue slices.  An attempt will 
be made to adjust the sectioning so that the cuts pass though the 
center of each thermal lesion in the sagittal plane.  
 
          Marking Inks: 
 
 
Treatment Site 1:   □  N/A         □  Color____________________ 
 
 
Treatment Site 2:   □  N/A         □  Color____________________ 
 
 
Treatment Site 3:   □  N/A         □  Color____________________ 
 
 
Digital Photographs of Unstained Uterine Tissue Slices: 
(include identifying tags and scale) 
 
□  Yes:  Total Number ____________  
 
□ No:   Comment :___________________________  
 
 
Uterine Lesions and Other Findings: 
 
a.  Leiomyomata:  
 
□   
Absent  
 
□  
Present 
– 
Number: 
____ 
 
Size 
Range: 
___ 
- 
 
___ 
cm;  
            
Location:_______________________________________________________  
             _______________________________________________________ 
                         
b.  Adenomyosis -  
  
 □ Present – Size: ___ x ___ x ___ cm; treated___  untreated__ 

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 □ 
Present 
– 
Size: 
___ 
x 
___ 
x 
___ 
cm; 
treated___ 
 
untreated__ 
 □ 
Present 
– 
Size: 
___ 
x 
___ 
x 
___ 
cm; 
treated___ 
 
untreated__ 
 □ 
Present 
– 
Size: 
___ 
x 
___ 
x 
___ 
cm; 
treated___ 
 
untreated__ 
 □ 
Present 
– 
Size: 
___ 
x 
___ 
x 
___ 
cm; 
treated___ 
 
untreated__ 
 □ 
Present 
– 
Size: 
___ 
x 
___ 
x 
___ 
cm; 
treated___ 
 
untreated__ 
 
            Description:_____________________________________________________  
    _____________________________________________________ 
                        
_____________________________________________________ 
 
 
c.  Other Findings:  
 
□  Absent  
 
□ 
 
Present 
- 
Description:_____________________________________________ 
            
 
______________________________________________________ 
                    
 
______________________________________________________ 
                     
______________________________________________________ 
6.  Macroscopic TTC-Staining Evaluation: 
 
The size and location of each treated area will be recorded with the minimum “ to 
serosa”  and “to intrauterine cavity” distances. Using the TTC-stained tissue slices, 
the size of the TTC-negative region will be measured. The involved tissues will be 
documented.  The lesion’s location within the area of adenomyosis will be 
documented. The approximate percentage of treated area will be estimated. The 
closest distance between the TTC-negative lesion and the serosa and intrauterine 
cavity will be recorded.  Measurements will be made with calipers to within ±0.1 
mm. 
 
 
Digital Photographs of TTC-Stained Uterine Slices:   
             (include identifying tags and scale) 
 
 □  Yes:  Total Number ____________  
 
 □ No:   Comment :________________________________ 
 
 
 
Treated Region #1 TTC-Staining Results:   
 
□  Section Not Applicable 
 
 
 
Adenomyosis Area: ___ x ___ x ___ mm (C/C x A/P x R/L) 
 

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                             Location:  □  Fundus  □  Cornu    □  Corpus  □  Lower Segment 
                                                                □  Anterior □  Posterior  □  Right   □  Left 
 
      TTC-Staining Results 
 
           □  TTC-Negative Lesion Not Identified     
 
           □  TTC-Negative Lesion Identified     
 
 
 
       Ablation Zone Size: _____ x _____ x _____ mm (C/C x A/P x R/L) 
 
                     
 
 
       Ablation Zone Relationship to Target: □  Central  □  Eccentric 
 
                         Approximate % of Ablated Tissue:  _____ % 
 
 
 
      Minimum Ablation to Cavity: _____mm                    to Serosa: _____mm 
 
                   Comment: ______________________________________________________ 
                     
             ______________________________________________________ 
                     
             ______________________________________________________ 
 
Treated Region #2 TTC-Staining Results:   
 
□  Section Not Applicable 
 
 
 
Adenomyosis Area: ___ x ___ x ___ mm (C/C x A/P x R/L) 
 
 
                             Location:  □  Fundus  □  Cornu    □  Corpus  □  Lower Segment 
                                                                □  Anterior □  Posterior  □  Right   □  Left 
 
      TTC-Staining Results 
 
           □  TTC-Negative Lesion Not Identified     
 
           □  TTC-Negative Lesion Identified     
 
 
 
       Ablation Zone Size: _____ x _____ x _____ mm (C/C x A/P x R/L) 
 
                     
 
 
       Ablation Zone Relationship to Target: □  Central  □  Eccentric 
 
                         Approximate % of Ablated Tissue:  _____ % 
 
 
 
      Minimum Ablation to Cavity: _____mm                    to Serosa: _____mm 
 
                   Comment: ______________________________________________________ 
                     
             ______________________________________________________ 
                     
             ______________________________________________________ 
 
Treated Region #3 TTC-Staining Results:   
 
□  Section Not Applicable 
 
 
 
Adenomyosis Area: ___ x ___ x ___ mm (C/C x A/P x R/L) 
 
 
                             Location:  □  Fundus  □  Cornu    □  Corpus  □  Lower Segment 
                                                                □  Anterior □  Posterior  □  Right   □  Left 
 
      TTC-Staining Results 
 
           □  TTC-Negative Lesion Not Identified     
 
           □  TTC-Negative Lesion Identified     
 
 
 
       Ablation Zone Size: _____ x _____ x _____ mm (C/C x A/P x R/L) 
 

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       Ablation Zone Relationship to Target: □  Central  □  Eccentric 
 
                         Approximate % of Ablated Tissue:  _____ % 
 
 
 
      Minimum Ablation to Cavity: _____mm                    to Serosa: _____mm 
 
                   Comment: ______________________________________________________ 
                     
             ______________________________________________________ 
                     
             ______________________________________________________ 
 
Treated Region #4 TTC-Staining Results:   
 
□  Section Not Applicable 
 
 
 
Adenomyosis Area: ___ x ___ x ___ mm (C/C x A/P x R/L) 
 
 
                             Location:  □  Fundus  □  Cornu    □  Corpus  □  Lower Segment 
                                                                □  Anterior □  Posterior  □  Right   □  Left 
 
      TTC-Staining Results 
 
           □  TTC-Negative Lesion Not Identified     
 
           □  TTC-Negative Lesion Identified     
 
 
 
       Ablation Zone Size: _____ x _____ x _____ mm (C/C x A/P x R/L) 
 
                     
 
 
       Ablation Zone Relationship to Target: □  Central  □  Eccentric 
 
                         Approximate % of Ablated Tissue:  _____ % 
 
 
 
      Minimum Ablation to Cavity: _____mm                    to Serosa: _____mm 
 
                   Comment: ______________________________________________________ 
                     
             ______________________________________________________ 
                     
             ______________________________________________________ 
 

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TTC-Negative Possible Satellite Thermal Lesions (submit tissue for histology): 
□  Not Identified     
□ 
 
Present 
– 
Describe 
size 
and 
locations: 
__________________________________________________ 
                     
_________________________________________________________________
________ 
                     
_________________________________________________________________
________ 
                     
_________________________________________________________________
________ 
7.  Representative Tissue Formalin-Fixation and Paraffin-Embedding 
for  
     Histologic Evaluation:  
Representative tissue blocks from each thermal lesion and any possible satellite 
lesions will be submitted for fixation in 10% neutral buffered formalin and 
routine paraffin-embedding. Each block will be labeled with the protocol 
number and location identifier. The blocks will be embedded at the local 
institution without slide preparation. 
      Submitted Histology Cassettes (Embed Only at Local Institution): 
      Location                         Cassette Letter 
                                                Identifiers (A,B,C…) 
      Lesion #1          
________ 
□   Not Submitted 
                 Cassette Map of Lesion: 
 
 
 
 
      Lesion #2 ________ 
□   Not Submitted 
                 Cassette Map of Lesion: 
 
 
 
 
 
     Lesion #3          
________ 
□   Not Submitted 
                  Cassette Map of Lesion: 
 
 
 
     ____________________  ________ 
□   Not Submitted 

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      ____________________  ________ 
□   Not Submitted 
      ____________________  ________ 
□   Not Submitted 
      ____________________  ________ 
□   Not Submitted 
      ____________________  ________ 
□   Not Submitted 
 
8.  Additional Observations and Comments:                              
      _______________________________________________________________ 
 
      _______________________________________________________________ 
      _______________________________________________________________ 
      _______________________________________________________________ 
      _______________________________________________________________ 
      _______________________________________________________________ 
      _______________________________________________________________ 
      _______________________________________________________________ 
 
 
 
 
Print Pathologist Name 
  
 
 
 
 
 
 
 
 
Signature of Pathologist 
  
 
 
 
 
 
 
 
 
Date 
 
_____/_____/_______  (DD/MMM/YYYY) 

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Appendix B – TTC Staining Protocol 

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TTC (Triphenyltetrazolium Chloride) Staining protocol for Macroscopic Tissue 
Viability Assessment 
Principal 
Regions of thermal necrosis will be identified using a dehydrogenase enzyme and cofactor based 
reaction that converts the tetrazolium salt to a formazan pigment within viable tissues. This 
conversion results in a cytochemical color change from colorless to red-maroon in tissues with 
preserved or partially preserved enzymatic activity (viable vs partially viable tissues). Tissues that 
lack intact enzymatic activity to metabolize the tetrazolium salt do not stain and remain their native 
color.   
 
Upon gross examination, the non-viable tissues appear pale pink-tan to yellow-grey in color 
depending on their baseline color. After staining, the boundary of the thermal necrosis, if present, 
can be assessed by identifying red-orange staining in the viable enzymatically active tissue. The 
protocol for preparing the TTC solution for tissue staining follows: 
Specimen Requirements 
Fresh tissue slices from the specimen maintained at room temperature after removal from the 
patient.  Testing should be performed within two – four hours of tissue excision from the patient. 
The tissue should not be allowed to dry or become excessively wet. Avoid rinsing tissue slices 
after cutting with water. 
Materials 
Sigma Chemical - Tel. 1-800-325-3010  Fax 1-800-325-5052 
 
Trizma HCl     Catalog #T3253-500g  
 
Trizma Base  Catalog #T1503-100g 
 
TTC                Catalog #T8877-100g 
Distilled water 
Stain Preparation 
The following amount of each chemical will be brought into solution in 1000 ml of distilled 
water: 
 
Trizma Base (Sigma #T 1503)    
7.88 gram 
 
Trizma HCl (Sigma #T 3253)   
21.28 gram 
 
T.T.C. (Sigma #T 8877)         
 
10.00 gram 
 
The stock staining solution must be stored in plastic non-metallic containers that are light-tight. 
The stock solution should be stored at 4ºC in the refrigerator. The stock solution expiration date 
should be no greater than 30 days from preparation.  The stain can be filtered and re-used provided 
significant dilution of the solution with tissue fluids has not occurred. 
 
In general, 1000 ml of stock staining solution should be sufficient for two to three uterine 
specimens. In general, no more than three uteri should be stained with 1000 ml of stock solution. 

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Procedure 
1. The cut surfaces should be free from excessive blood and other tissue fluids prior to 
cutting. The cut surfaces should not be allowed to dry (cut on saline dampened toweling). 
The cut surfaces should not be rinsed with water or other fixatives. 
2. Fresh cut tissue surfaces will be floated cut surface down in a non-metallic plastic 
container of the TTC staining solution. Staining will be performed at room temperature 
for a period of 60 minutes or optimal color change is achieved. 
3. Following staining, the tissue will be fixed in 10% formalin to intensify and sharpen the 
stain (range: 5 min. up to 24 hours). 
4. Digital photographs will be taken and the results measured. 
 
Results 
       Staining Interpretation: 
 
Viable tissue stains red-maroon   
 
Non-viable tissue lacks staining. 
 
As TTC staining can fade over time, macroscopic tissue evaluation should be made within 12 to 24 
hours of staining.  False negative staining can occur in regions where the tissue contacts the 
container or other surfaces during staining. TTC staining of fresh tissue does not affect formalin 
fixation, paraffin embedding and subsequent hematoxylin and eosin staining. 
 

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Appendix C – Microscopic Pathology Case Report Form 
 
 

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Microscopic Uterine 
Pathology Evaluation 
Hologic, Inc. 
Subject ID:  
Institution / Site Number: 
Uterus ID Number (Hosp. Number): 
Test Article: ProVu 
Test System: In Vivo Human Adenomyosis 
Specimen Type:  Human Uterus 
Surgery Date:                                     (DD/MMM/YYYY) 
 
Microscopy Date:                              (DD/MMM/YYYY) 
1. Received Histology Cassettes Embedded at Local Institution: 
Labeled: ______________________ (Specimen Number) 
 
Letter 
Identifier(s) Location 
Status 
_________  
Lesion #1 
  
□  Received 
□   Not Received 
_________  
Lesion #2 
  
□  Received 
□   Not Received 
_________  
Lesion #3 
  
□  Received 
□   Not Received 
_________  
Lesion $4 
  
□  Received 
□   Not Received 
_________  
_____________________  
□  Received 
□   Not Received 
_________  
_____________________  
□  Received 
□   Not Received 
_________  
_____________________  
□  Received 
□   Not Received 
_________  
_____________________  
□  Received 
□   Not Received 
 
2.  Hematoxylin and Eosin Sections:                              
The received paraffin-embedded blocks will be faced and a 5 micron hematoxylin and 
eosin stained section will be prepared for review from each block. Microscopic 
measurements will not be made on these slides. A general summation will be provided with 
specific comments referenced by location ID (see figure). 
 
 
General Summary:     
      __________________________________________________________________________ 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
 
 
Slide Specific Comments: 
ID 
Additional Finding(s) if present: 
 

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A. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
B. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
C. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
D. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
E. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
F. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
G. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
H. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
I. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
J. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
K. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
L. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
M. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
N. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
O. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
P. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
Q. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
R. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
S. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
T. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
U. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
V. 
□  NA   □  No Additional     □ 
__________________________________________________________ 

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W. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
X. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
Y. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
Z. 
□  NA   □  No Additional     □ 
__________________________________________________________ 
 
3.  Additional Observations and Comments:                              
      __________________________________________________________________________ 
 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
      __________________________________________________________________________ 
 
 
 
 
Print Pathologist Name 
  
 
 
 
 
 
 
 
 
Signature of Pathologist 
  
 
 
 
 
 
 
 
 
Date 
 
_____/_____/_______  (DD/MMM/YYYY)