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Recruiting Not applicable Interventional

Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

ClinicalTrials.gov ID: NCT07290517

Public ClinicalTrials.gov record NCT07290517. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT07290517
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Indiana University
Other
Enrollment
100 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 10, 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027
Last update posted
Aug 12, 2026

2026 – 2027

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Indiana University Hospital Indianapolis Indiana 46202 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07290517, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 12, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07290517 live on ClinicalTrials.gov.

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