Status:
COMPLETED
Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures
Lead Sponsor:
Indiana University
Conditions:
Intrauterine Device (IUD)
Abnormal Uterine Bleeding
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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,...
Eligibility Criteria
Inclusion
- • 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
- • Vaginal bleeding of unknown origin
- Cervix less than 26 mm in diameter
- Nabothian cyst on anterior lip of cervix
- Cervical myomas
- Cervical abnormalities
- Pregnant
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06193590
Start Date
November 9 2023
End Date
April 15 2024
Last Update
June 10 2025
Active Locations (1)
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1
Indiana University Hospital
Indianapolis, Indiana, United States, 46202