Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Not Applicable

Completed

• Conditions: Intrauterine Device (IUD); Abnormal Uterine Bleeding
• Interventions: Device: Carevix; Device: Tenaculum

• Registration Number: NCT06193590
• Lead Sponsor: Indiana University

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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-09
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carevix	Carevix	suction cervical stabilizer utilized for intrauterine procedures
Tenaculum	Tenaculum	standard of care cervical stabilization device

Primary Outcome Measures

Name	Time	Method
Patient-perceived pain	Upon cervical stabilization, and immediately after intrauterine procedure is complete	Patients will be asked to rate their pain on a 10 point Likert scale. Lower numbers represent lower pain.

Secondary Outcome Measures

Name	Time	Method
Provider-perceived satisfaction	Immediately after intrauterine procedure is complete	Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response.
Provider-perceived bleeding	Immediately after intrauterine procedure is complete	Bleeding perceived by the provider during and after the procedure
Provider-perceived ease of use	Immediately after intrauterine procedure is complete	Providers will report their perceived ease of use indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States