Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

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

NCT Number	NCT07290517
Lead Sponsor	Indiana University Collaborators: Aspivix SA
Conditions	IUD, Abnormal Uterine Bleeding, Pain, Cervical
Enrollment	100 participants
Start Date	2026-03-11
Primary Completion	2027-03 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-08-13