Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07290517
Status
Recruiting
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Conditions

  • Abnormal Uterine Bleeding
  • IUD
  • Pain, Cervical

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carevix — DEVICE
    Vacuum cervical stabilization device
  • Tenaculum — DEVICE
    Standard of care cervical stabilization device

Study Details

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

Key Dates

First listed
Dec 18, 2025
Start date
Mar 11, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Carevix
    Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion.
  • Active Comparator: Tenaculum
    Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion.

Primary Outcome Measure

Patient pain score [ Time Frame: During Procedure (at Cervix Grasping, at Cervix Traction, and at IUD placement) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University HospitalIndianapolisIndiana46202
Alissa M Conklin, MD
[email protected]
317-944-8231

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By research site
Indiana University Hospital· Indianapolis, IN

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