What is the Carevix device studying for IUD insertion pain?

The study is comparing patient-reported pain during IUD insertions using the new Carevix suction device versus the standard tenaculum. Researchers want to see if Carevix reduces pain and also assess provider ease of use. Indiana University is leading this research to better understand options during IUD placement.

Who may be eligible for this IUD insertion clinical trial?

Women 18 years or older scheduled for an IUD insertion within 90 days may be eligible. They must be able to consent and have a planned cervical stabilization device used by a trained provider. Participants who are pregnant or have certain cervical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this IUD insertion clinical trial?

Study-related care, including the device used and all trial visits, is provided at no cost. However, personal travel expenses to attend the visits may vary and are not guaranteed to be covered. Participants can plan accordingly for any travel needs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

FEMALE

ID07290517

Comparing Pain and Usability of Carevix Suction Device versus Standard Tenaculum for IUD Insertion in Women

Led by Indiana University · Updated on 2026-07-06

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating patient-reported pain, bleeding, and the efficiency of devices used during intrauterine device IUD insertions. This trial compares a new FDA-approved, atraumatic suction cervical stabilizer called Carevix with the standard single-tooth tenaculum, which is considered more traumatic. The study also looks at provider satisfaction and ease of use for these devices, focusing on differences in pain scores between patients who have never given birth nulliparous and those who have multiparous. Participants will be randomly assigned to receive either the Carevix device or the standard tenaculum during their IUD insertion procedure. Providers will perform the procedures using the assigned device, and participants will complete surveys about their pain experience and satisfaction immediately after the procedure. The study collects additional information on cultural background, previous contraceptive use, and reasons for choosing IUD insertion or anticipating removal. During the trial, participants will be evaluated for pain at several points before the procedure, during cervix grasping and traction, at IUD placement, and five minutes after completion. Providers will assess ease of device use, number of placement attempts, bleeding, and overall satisfaction right after the procedure. Patient satisfaction and bleeding cessation time will also be measured. The study runs from March 2026 to March 2027, with ongoing assessments during and immediately after the IUD insertion.

CONDITIONS

Brief Title

Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Able to give informed consent independently
Scheduled for IUD insertion within 90 days of consent
Planned use of a cervical stabilization device during insertion
Procedure performed by a trained provider
Provider willing to use the Carevix device for the procedure

You will not qualify if you...

Vaginal bleeding of unknown cause
Cervix diameter less than 26 mm
Presence of Nabothian cyst on anterior cervix
Cervical myomas
Abnormal cervical shape
Pregnancy
Not fluent in English or unable to fully understand consent
Unable to provide informed consent
Initial IUD placement attempt without cervical stabilization device

Research Team

Alissa M Conklin, MD

Kylie L Williams, MA

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