Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

NCT ID
NCT07290517
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Indiana University
Conditions
Abnormal Uterine Bleeding, IUD, Pain, Cervical

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: The Carevix Device: Assessing Pain and Effectiveness of a Suction-based Cervical Stabilizer for IUD Insertions in the Clinic Setting: a Randomized, Controlled Trial (CARE)

Enrollment: 100 participants (Estimated).

What is being studied

  • Device: Carevix
  • Device: Tenaculum

Who may be eligible

Ages
18 Years to no maximum
Sex
Female
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria (to be assessed prior to procedure): * Age 18 years or older * Able to consent on their own * Scheduled and will undergo an IUD insertion within 90 days of consent * Planned use of cervical stabilization device for placement * Procedure being performed by a trained provider * Provider is willing to use Carevix™ for scheduled procedure Exclusion Criteria (to be assessed by provider at time of procedure): * Vaginal bleeding of unknown origin * Cervix less than 26 mm in diameter * Nabothian cyst on anterior lip of cervix * Cervical myomas * Cervical abnormalities/shape * Pregnant * Participants who are not fluent in and/or do not fully understand, read, write, or speak the English language * Other inability to provide informed consent to participate * Initial attempt to place the IUD without any cervical stabilization

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Indiana, United States: 1

Sample of listed locations

  • Indiana University Hospital — Indianapolis, Indiana, 46202, United States — Recruiting

Study details

Start date
March 11, 2026
Primary completion date
March 1, 2027
Completion date
March 1, 2027
First posted
December 18, 2025
Collaborators
Aspivix SA

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07290517
Registry last updated
August 13, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07290517 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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