N/A
N=73
Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures
Intrauterine Device (IUD) · Abnormal Uterine Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT06193590 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Patient-perceived Pain — 3; 4 score on a scale — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carevix (Device); Tenaculum (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-perceived Pain |
3; 4 | 0.21 |
| SECONDARY Provider-perceived Bleeding |
3; 9; 27; 21 | 0.1 |
| SECONDARY Provider-perceived Ease of Use |
12; 17; 1; 0; 0 | — |
| SECONDARY Provider-perceived Satisfaction |
14; 2; 10; 8; 0; 16 | 0.001 sig |
Summary
To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.
Eligibility Criteria
Inclusion Criteria
- • 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)
- Cervix at least 26 mm in diameter
- Twenty providers performing this procedure
Exclusion Criteria
- • Vaginal bleeding of unknown origin
- Cervix less than 26 mm in diameter
- Nabothian cyst on anterior lip of cervix
- Cervical myomas
- Cervical abnormalities
- Pregnant
Data sourced from ClinicalTrials.gov (NCT06193590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.