Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Not Applicable

Completed

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

• 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
• Results First Submitted: 2025-04-15
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Results First Posted: 2025-06-10
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

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

Primary Outcome Measures

Name	Time	Method
Patient-perceived Pain	Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)	Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded.

Secondary Outcome Measures

Name	Time	Method
Provider-perceived Bleeding	Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)	Bleeding perceived by the provider during and after the procedure.
Provider-perceived Ease of Use	Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)	Providers will report their perceived ease of use with the Carevix device indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response.
Provider-perceived Satisfaction	Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)	Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded.

Trial Locations

Locations (1)

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