Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Completed · Not applicable

Conditions studied: Intrauterine Device (IUD), Abnormal Uterine Bleeding

In brief

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.

Key facts

Study ID

NCT06193590

Run by

Indiana University

People needed

73

Starts

2023-11-09

Expected to finish

2024-04-15

Last updated by the study team

2025-06-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• • 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

You may not qualify if…

• • Vaginal bleeding of unknown origin
• Cervix less than 26 mm in diameter
• Nabothian cyst on anterior lip of cervix
• Cervical myomas
• Cervical abnormalities
• Pregnant

Where it is running

• Indiana University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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