Not Yet RecruitingNot Applicable

Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

United States100 participantsStarted 2026-02

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient pain score (Numeric Pain Rating Scale)

Timeframe: During IUD insertion procedure

Trial details

NCT IDNCT07290517

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Alissa M Conklin, MD

317-944-8231 alconkli@iu.edu