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Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

NCT07290517 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-14

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between IUD insertions using a suction cervical stabilizer (new device, FDA approved, atraumatic) and single-tooth tenaculum (standard, traumatic). Our aims are to:

* assess and compare patient-reported pain during IUD insertion between the Carevix device and tenaculum.
* assess predictors of pain scores including between nulliparous and multiparous patients
* assess provider-reported ease of use and satisfaction

Participants (including providers) will:

* be randomized to receive one device to complete the IUD procedure
* complete a survey following the procedure

Conditions

  • IUD
  • Abnormal Uterine Bleeding
  • Pain, Cervical

Interventions

DEVICE

Carevix

Vacuum cervical stabilization device

DEVICE

Tenaculum

Standard of care cervical stabilization device

Sponsors & Collaborators

  • Aspivix SA

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Alissa M Conklin, MD · Indiana School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07290517 on ClinicalTrials.gov