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Recruiting NCT07290517

Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

Conditions: IUD, Abnormal Uterine Bleeding, Pain, Cervical

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Indiana University

Location: Indiana University Hospital Indianapolis Indiana

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07290517). StuddyBuddy aggregates publicly available trial information.