Safety and Efficacy of a Suction Cervical Stabilizer Compared to the Standard Tenaculum for Intrauterine Procedures in the Clinic Setting
Phase: NA
Conditions: Intrauterine Device (IUD), Abnormal Uterine Bleeding
Sponsor: Indiana University

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Safety and efficacy of a suction cervical stabilizer compared to 
the standard tenaculum for intrauterine procedures in the clinic 
setting 
 
Alissa Conklin, MD, FACOG 
Assistant Professor 
Department of Obstetrics & Gynecology 
Indiana University 
550 N University Blvd 
Suite 2441 
Indianapolis, IN 46202 
 
 
 
Jeffrey Peipert, MD, FACOG 
Professor and Chair 
Department of Obstetrics and Gynecology  
Indiana University 
Support Provided by: 
Aspivix 
 
 

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Table of Contents: 
Study Schema 
1.0 
Background & Rationale 
2.0 
Objective(s) 
2.1 
Primary Objective 
2.2 
Secondary Objective 
2.3 
Tertiary/Exploratory/Correlative Objectives 
3.0 
Outcome Measures 
3.1 
Primary Outcome Measures 
3.2 
Secondary Outcome Measures 
3.3 
Tertiary/ Exploratory/ Correlative Outcome Measures 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
4.2 
Exclusion Criteria 
4.3 
Other Criteria 
5.0 
Study Design 
6.0 
Enrollment 
7.0 
Study Procedures 
8.0 
Study Calendar 
9.0 
Reportable Events 
10.0 
Data Safety Monitoring 
11.0 
Study Withdrawal/Discontinuation 
12.0 
Statistical Considerations 
13.0 
Data Management 
14.0 
Privacy/Confidentiality Issues 
15.0 
Follow-up and Record Retention 
16.0 
References 
Appendix

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Abbreviations 
AE 
Adverse Event 
HIPAA 
Health Insurance Portability and Accountability Act  
IRB 
Institutional Review Board 
PI 
Principal Investigator 
PHI 
Personal Health Information 
RCT 
Randomized Controlled Trial 
SAE 
Serious Adverse Event 
US 
United States 
IUD 
Intrauterine Device 
EMB 
Endometrial Biopsy 
FDA 
Food and Drug Administration 
 
 

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1.0 Background & Rationale 
When intrauterine procedures are performed, often the cervix needs to be stabilized to facilitate 
intrauterine entry.  The standard approach for cervical stabilization is an invasive, sharp instrument 
called a tenaculum.  This leaves two punctures on the cervix, which can be painful and bleed, which can 
prolong any intrauterine procedure (IUD insertion, endometrial biopsy, etc).  Aspivix ™ has created a 
suction-based atraumatic cervical stabilizer for use with such intrauterine procedures.  The First-in-
Woman study (RCT with 100 patients) completed in 2 renowned University Hospitals in Switzerland 
showed positive results (pain reduced by up to 73% and bleeding occurrence reduced by 78%). This new 
device is fully FDA approved.   
 
I've attached the company's data and the clinical brochure showing the device, explaining how it is used, 
and data on effectiveness.  In addition, this is their RCT publication on the journal Contraception on this 
device, showing the data cited above (Attachment #1). 
https://www.contraceptionjournal.org/article/S0010-7824(23)00066-5/fulltext 
 
Aspivix ™ launched the AMBASSADOR PROGRAM, a 3–6-month program with free of charge devices for 
selected hospitals /clinics willing to test extensively Carevix™ in multiple transcervical procedures. 
 
2.0 Objective(s) 
2.1 
Primary Objective 
2.1.1 
Primary Objective: to assess patient-reported pain and provider-reported 
bleeding.  Our hypothesis is that patient-reported pain and provider-reported 
bleeding comparing Carevix™ to tenaculum will be similar in our American 
population and with all intrauterine procedures as it was in the European study 
and with only IUD insertions. 
2.2 
Secondary Objective 
2.2.1 
Secondary Objective: to assess provider-reported ease of use and provider 
satisfaction. 
 
3.0 Outcome Measures/Endpoints 
3.1 
Primary Outcome Measures 
3.1.1 
Primary outcome measures: To assess patient-reported pain, a questionnaire 
provided by Aspivix ™ (Attachment #2) will be done after completing the 
procedure.  This takes, on average, 1 minute to complete. 
3.2 
Secondary Outcome Measures 
3.2.1 
Secondary outcome measures: To assess provider-reported bleeding, ease of 
use and provider satisfaction with the device, the provider will complete a 
questionnaire following the patient’s completion of their portion of the 
questionnaire (Attachment #2).  This takes, on average, 2 minutes to complete. 
 
 
4.0 Eligibility Criteria 

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4.1 
Inclusion Criteria (to be assessed prior to procedure) 
• 
Age 18 years or older 
• 
Speaks and reads in English  
• 
Able to consent on their own 
• 
Will undergo any intrauterine procedure using the Carevix™ (for exposure 
group) or using Tenaculum (for Control Group) 
• 
Up to 20 providers performing this procedure 
• 
Provider is willing to use Carevix™ for scheduled procedure 
 
4.2 
Exclusion Criteria (to be assessed by provider at time of procedure) 
• 
Vaginal bleeding of unknown origin 
• 
Cervix less than 26 mm in diameter 
• 
Nabothian cyst on anterior lip of cervix 
• 
Cervical myomas 
• 
Cervical abnormalities/shape 
• 
Pregnant 
 
4.3 
Other Criteria 
4.3.1 
If the patient does not require ANY cervical stabilization after consent into 
either study arm, the subject status will be considered ineligible and the patient 
will not be required to complete any surveys.  
 
 
5.0 Study Design 
Aspivix, the company that created Carevix™, launched the Ambassador Program, a 3-6 month program 
with free of charge devices for clinics willing to test Carevix™ in multiple intrauterine procedures.  Our 
clinic, Coleman Center, will conduct a prospective cohort study for 3-6 months where patients who 
qualify via inclusion criteria who are also receiving an intrauterine procedure (endometrial biopsy, IUD 
insertion, manual aspiration, etc) on the exposure (Carevix™) arm will have the opportunity to receive 
the Carevix™ device for cervical stabilization, per provider preference (i.e., providers may decline to use 
Carevix™ for endometrial biopsy).  
Once 25 participants have received Carevix™, recruitment for the control (tenaculum) arm will begin. 
Participants will receive the standard of care device if cervical stabilization is required. Each participant 
will be provided with a study information sheet and sign a consent form. They will then undergo their 
planned procedure, using the assigned device.  
Following completion of their procedure, they will also agree to fill out a survey about their experience, 
which takes about 1 minute to complete.  The provider performing the procedure will finish the survey 
with provider-specific questions about bleeding, ease of use and satisfaction. The purpose of this study 
is to compare Carevix™ to the tenaculum and determine if the Carevix™ shows similar results in the 
United States population as it has in the European study and with all intrauterine procedures. 
 
 

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Flow diagram for prospective cohort study 
Prior to enrollment    
 
 
Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
Total N 60: Screen potential participants by inclusion 
criteria.  Obtain informed consent.  Obtain history.  
Document. 
Recruited to Tenaculum or 
ineligible for Carevix™ arm* 
Recruited to Carevix™ arm* 
Fills out tenaculum survey after 
procedure 
Fills out Carevix™ survey after 
procedure 
Provider fills out provider portion 
of survey after participant 
*Once 25 of 30 patients received 
Carevix™, will commence control group 
collection  
N = 30 
Once 60 total surveys 
collected, end study 
No cervical stabilization 
required or excluded: off study 
Receives tenaculum 
Receives Carevix™ if no 
exclusion criteria are met 

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6.0 Enrollment 
We intend to enroll twenty-five evaluable Carevix subjects prior to commencing the enrollment of the 
control-group tenaculum subjects.  An additional five Carevix subjects (for a total of N=30) will be 
concurrently enrolled while accruing the thirty additional tenaculum subjects for a total enrollment of 
N=60.  
7.0 Study Procedures 
Any intrauterine procedure already scheduled will otherwise proceed accordingly as part of clinical care. 
During the enrollment, patients who fit above inclusion criteria and are scheduled for an intrauterine 
procedure may be offered the opportunity to participate in this program and trial the new Carevix™ 
device during the exposure recruitment period and complete a short survey. If the patient consents to 
the use of Carevix™ Ambassador program, the suction-based cervical stabilizer will be used on their 
cervix to stabilize the cervix during the procedure instead of the traditional tenaculum. If the patient or 
provider opts out of the use of Carevix™, they will be asked if they’d like to participate in the study with 
the tenaculum. During the tenaculum enrollment phase, patients will receive the standard of care 
device and complete a short survey. 
Following completion of the procedure, the patient will then fill out the patient-based survey.  Following 
the completion of the patient’s questions, the provider will then fill out the provider-based survey. 
The questionnaire for the Carevix™ Ambassador program will be stored within the Aspivix company 
database (all questions are HIPAA compliant and do not reveal PHI).  The survey is labeled as originating 
from Indiana University for easy access to only our patient data. 
8.0 Study Calendar 
There is no study calendar – the patient will have their intrauterine procedure scheduled and will decide 
if they wish to participate in the Carevix™ Ambassador program or not.  The event will be a one-time 
procedure only when the Carevix™ suction-based cervical stabilizer is used or the tenaculum is used.   
9.0 Reportable Events 
It is not anticipated that there will be Serious Adverse Effects as defined by the FDA (death, life-
threatening complications, need for hospitalization, disability or permanent damage, or an intervention 
needed to prevent permanent impairment or damage). However, if one occurs, it will be promptly 
reported to the IU IRB and sponsor (within 5 days of knowing about the occurrence) and per IU HRPP 
policy if unexpected, related/possibly related to participation and if the SAE suggests that the research 
places the subject or others at greater risk of harm. 
Other adverse events (AE) that may occur with any cervical stabilization device, such as bleeding or 
injury at stabilization site needing medication or surgical intervention, are common and will be collected 
and reported as part of study data and at annual regulatory reviews. 
10.0 
Data Safety Monitoring 

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This study is no greater than minimal risk. Data safety and monitoring will be performed by the database 
manager for the Qualtrics database and the PI. Data quality, subject recruitment data completion, 
outcome and adverse event data, and proper consent procedures will be regularly reviewed by the PI, 
study coordinator, and data manager at least monthly. A formal Data Safety Monitoring Board is not 
required. While no formal stopping criteria are proposed, monitoring of AEs will be ongoing and will be 
discussed by the PI and Department representatives if the AE rate (notably bleeding or injury to the 
stabilization site on the cervix) is above 50%. 
11.0 
Study Withdrawal/Discontinuation 
Patients can decline participation and will receive standard of care if cervical stabilization is required. 
Patients who consent to receiving the Carevix™ and who require no cervical stabilization or is assessed 
by the provider to be otherwise ineligible for the device will be considered ineligible if they do not 
receive tenaculum (unless consented for tenaculum) and will not be required to complete any surveys or 
follow-ups.  
12.0 
Statistical Considerations 
We performed sample size/power calculations with the primary outcome of pain (visual analog scale) at 
the time of Carevix™/tenaculum use. Thirty participants per group (total N=60) are needed to achieve at 
least 80% power and a two-sided 5% significance level. Descriptive characteristics of those in the 
Carevix™ and control groups will be compared using standard statistical testing such as Chi-square and t-
tests. Differences in outcomes between the device and control groups will similarly utilize standard 
testing.  
13.0 
Statistical Data Management 
Primary data for the exposure group (e.g. the Carevix™ group) will be collected via Aspivix’s secure 
server.  Aspivix has agreed in the Ambassador Agreement to allow access to their data.  In the provider 
section of the survey will be a link to select location site and these data will be separately accessible.  
The surveys for the patient and provider are connected within the same survey.  The data for the control 
group (e.g. the tenaculum group) will be collected and stored via RedCap, using similar questions to the 
exposure survey. Aspivix will also furnish us with raw data that will allow us to correlate the date and 
time of the submitted survey with the date and time of the patient’s consented information. This data 
will be documented in RedCap for the purpose of data analysis. The signed consent forms will be stored 
in a secure and lockable cabinet. 
14.0 
Privacy/Confidentiality Issues 
None of the questions on the data collection questionnaire will contain PHI.  Data will be stored within 
the company Aspivix’s secure server and on RedCap. 
15.0 
Follow-up and Record Retention 
The study will last about 1 year (6 months for Carevix™ exposure group and approximately 6 months for 
the control group (e.g. tenaculum).  The record retention will be indefinite.   
16.0 
References 

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Yaron M, et al.  Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device 
insertion: Results from a randomized, controlled study.  Contraception.  Vol 123, July 2023. 
https://www.contraceptionjournal.org/article/S0010-7824(23)00066-5/fulltext 
17.0 
Appendix 
Attachment #1: Carevix™ data published in the journal Contraception. 
Attachment #2: Questionnaire for patients and providers (done through the same link). 
Attachment #3: Study information sheet and consent form.