Assessing Pain and Effectiveness of Carevix Device for IUD Insertions (NCT07290517) | Clinical Trial Compass
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 range
18 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.