Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Last updated: March 5, 2025
Sponsor: Indiana University
Overall Status: Completed

Phase

N/A

Condition

Heavy Bleeding / Heavy Periods

Dysfunctional Uterine Bleeding

Uterine Disorders

Treatment

Tenaculum

Carevix

Clinical Study ID

NCT06193590
19699
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

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

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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Tenaculum
Phase:
Study Start date:
November 09, 2023
Estimated Completion Date:
April 15, 2024

Connect with a study center

  • Indiana University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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