Trial Outcomes & Findings for Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures (NCT NCT06193590)
NCT ID: NCT06193590
Last Updated: 2025-06-10
Results Overview
Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded.
COMPLETED
NA
73 participants
Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
2025-06-10
Participant Flow
Patients were recruited from a women's health clinic in Indianapolis. Enrolled participants were at least 18 years old, English-speaking, and scheduled to undergo an intrauterine procedure. A total of 73 patients were enrolled with 60 eligible participants who received cervical stabilization during their procedure.
Patients were ineligible if they did not meet these criteria, as well as if they presented with vaginal bleeding of unknown origin, cervix less than 26 mm in diameter, Nabothian cyst on anterior lip of cervix, cervical myomas, cervical abnormalities/shape, or if they were pregnant. Patients were also designated ineligible if they did not receive any cervical stabilization. Patients were recruited in two waves corresponding with each arm.
Participant milestones
| Measure |
Carevix
Suction cervical stabilizer utilized for intrauterine procedures
Carevix: Cervical stabilization device that uses vacuum
|
Tenaculum
Standard of care cervical stabilization device
Tenaculum: standard of care cervical stabilization device
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Carevix
n=30 Participants
Suction cervical stabilizer utilized for intrauterine procedures
Carevix: Cervical stabilization device that uses vacuum
|
Tenaculum
n=30 Participants
Standard of care cervical stabilization device
Tenaculum: standard of care cervical stabilization device
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (years) · 18-19
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Age, Customized
Age (years) · 20-30
|
14 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
Age, Customized
Age (years) · 31-40
|
8 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Age, Customized
Age (years) · 41-50
|
6 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
14 Participants
n=60 Participants
|
|
Age, Customized
Age (years) · 51-60
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Age, Customized
Age (years) · 61+
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Age, Customized
Age (years) · Missing
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Marital Status
Single
|
13 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
26 Participants
n=60 Participants
|
|
Marital Status
Domestic partnership (or living together but not married)
|
5 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
|
Marital Status
Married
|
10 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
23 Participants
n=60 Participants
|
|
Marital Status
Divorced
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Marital Status
Other
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Marital Status
Prefer not to say
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Highest level of complete education
Less than High School
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Highest level of complete education
High School, GE, or equivalent
|
11 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
16 Participants
n=60 Participants
|
|
Highest level of complete education
Some college
|
0 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
|
Highest level of complete education
Associate, Technical, or 2 year degree
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
|
Highest level of complete education
Bachelor's or 4 year degree
|
10 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Highest level of complete education
Master's degree
|
3 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
8 Participants
n=60 Participants
|
|
Highest level of complete education
Doctorate
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Highest level of complete education
License or Professional Certification
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Highest level of complete education
Other
|
2 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Highest level of complete education
Prefer not to say
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Employment Status
Unemployed
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
|
Employment Status
Student
|
3 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Employment Status
Part-time (less than 40 hours a week)
|
3 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Employment Status
Full-time (40+ hours a week)
|
16 Participants
n=30 Participants
|
19 Participants
n=30 Participants
|
35 Participants
n=60 Participants
|
|
Employment Status
Self-employed, Freelance, or Contractor
|
2 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
|
Employment Status
Retired
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Employment Status
Other
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Employment Status
Prefer not to say
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Employment Status
Student and Part-time
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Employment Status
Student and Full-time
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Employment Status
Missing
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Nulliparous/Multiparous
Nulliparous
|
12 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
25 Participants
n=60 Participants
|
|
Nulliparous/Multiparous
Multiparous
|
18 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
35 Participants
n=60 Participants
|
|
Nulliparous/Multiparous
Vaginal delivery
|
14 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
30 Participants
n=60 Participants
|
|
Nulliparous/Multiparous
Caesarean Section delivery
|
4 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)Population: Participants who underwent an intrauterine procedure with either the Carevix device or the Tenaculum.
Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded.
Outcome measures
| Measure |
Carevix
n=30 Participants
Suction cervical stabilizer utilized for intrauterine procedures
Carevix: Cervical stabilization device that uses vacuum
|
Tenaculum
n=30 Participants
Standard of care cervical stabilization device
Tenaculum: standard of care cervical stabilization device
|
|---|---|---|
|
Patient-perceived Pain
|
3 score on a scale
Interval 2.0 to 4.75
|
4 score on a scale
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)Population: Providers who completed the intrauterine procedure with their respective participants.
Bleeding perceived by the provider during and after the procedure.
Outcome measures
| Measure |
Carevix
n=30 Participants
Suction cervical stabilizer utilized for intrauterine procedures
Carevix: Cervical stabilization device that uses vacuum
|
Tenaculum
n=30 Participants
Standard of care cervical stabilization device
Tenaculum: standard of care cervical stabilization device
|
|---|---|---|
|
Provider-perceived Bleeding
Had to manage/stop bleeding on cervical tissues
|
3 Participants
|
9 Participants
|
|
Provider-perceived Bleeding
Did not have to manage/stop bleeding
|
27 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)Population: Providers were only asked about the "Ease of use" for the Carevix device.
Providers will report their perceived ease of use with the Carevix device indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response.
Outcome measures
| Measure |
Carevix
n=30 Participants
Suction cervical stabilizer utilized for intrauterine procedures
Carevix: Cervical stabilization device that uses vacuum
|
Tenaculum
Standard of care cervical stabilization device
Tenaculum: standard of care cervical stabilization device
|
|---|---|---|
|
Provider-perceived Ease of Use
Strongly Agree
|
12 Participants
|
—
|
|
Provider-perceived Ease of Use
Agree
|
17 Participants
|
—
|
|
Provider-perceived Ease of Use
Disagree
|
1 Participants
|
—
|
|
Provider-perceived Ease of Use
Strongly Disagree
|
0 Participants
|
—
|
|
Provider-perceived Ease of Use
I don't know/Not sure
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)Population: Providers who completed the intrauterine procedure with their respective participants.
Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded.
Outcome measures
| Measure |
Carevix
n=30 Participants
Suction cervical stabilizer utilized for intrauterine procedures
Carevix: Cervical stabilization device that uses vacuum
|
Tenaculum
n=30 Participants
Standard of care cervical stabilization device
Tenaculum: standard of care cervical stabilization device
|
|---|---|---|
|
Provider-perceived Satisfaction
I don't know not sure
|
0 Participants
|
16 Participants
|
|
Provider-perceived Satisfaction
Strongly Agree
|
14 Participants
|
2 Participants
|
|
Provider-perceived Satisfaction
Agree
|
10 Participants
|
8 Participants
|
|
Provider-perceived Satisfaction
Disagree
|
5 Participants
|
3 Participants
|
|
Provider-perceived Satisfaction
Strongly Disagree
|
1 Participants
|
1 Participants
|
Adverse Events
Carevix
Tenaculum
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place