MedTrace Logo

Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

NCT06193590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-06-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Intrauterine Device (IUD)
  • Abnormal Uterine Bleeding

Interventions

DEVICE

Carevix

Cervical stabilization device that uses vacuum

DEVICE

Tenaculum

standard of care cervical stabilization device

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Alissa Conklin, MD · Indiana University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2024-04-15
Completion
2024-04-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193590 on ClinicalTrials.gov