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Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

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)

Who can join

Ages 18 and older · Women

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

About the study

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

What is being tested

• Carevix (device)
• Tenaculum (device)

Sponsor: Indiana University · Participants: 100 · Started: Mar 11, 2026

Contact the study team

• Alissa M Conklin, MD · Phone: 317-944-8231

Official record on ClinicalTrials.gov — NCT07290517

Locations in the U.S.

Conditions

• Neck Injuries and Disorders
• Pain

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.