Carevix device vs. tenaculum for IUD insertion
Official title: 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)
Run by Indiana University · NCT07290517 · Data updated 2026-11-12
This study tests whether using the Carevix suction cervical stabilizer during IUD insertion reduces patient-reported pain compared with the standard tenaculum.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07290517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older undergoing an IUD insertion who are willing to use the Carevix device and can consent in English.
✕Probably not a fit
Patients who have contraindications to the Carevix device or whose procedures do not require cervical stabilization may not experience added benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two approaches for cervical stabilization during IUD placement: the new FDA-approved Carevix device and the conventional single-tooth tenaculum. Participants are randomized to receive one stabilization method during an IUD insertion and complete surveys on pain, bleeding, and satisfaction from both patient and provider perspectives. The study examines predictors of pain, including parity, and evaluates usability and success in completing the insertion with each device. Additional data on demographics, prior contraception, and potential barriers to removal are collected to inform future practice. The primary outcome is patient-reported pain during insertion, with secondary outcomes including usability, efficacy, bleeding, and satisfaction.
Why it matters
Potential benefit: If successful, the Carevix device could reduce pain and improve the ease of IUD insertion for patients and providers.
How similar studies have gone: Prior work suggests that alternative cervical stabilization approaches can affect pain and usability, but this direct comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Indiana University Hospital
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Alissa M Conklin, MD — Indiana School of Medicine
- Study coordinator: Alissa M Conklin, MD
- Email: alconkli@iu.edu
- Phone: 317-944-8231
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Combined hysteroscopic and laparoscopic repair for cesarean scar niche
This trial will try a combined hysteroscopic and laparoscopic surgical repair to treat women with symptomatic cesarean scar niches who have postmenstrual spotting.
-
BT-114143 injection for treating abnormal uterine bleeding.
This trial will test whether different doses of BT-114143 can safely reduce heavy menstrual bleeding in premenopausal women with abnormal uterine bleeding.
-
Using a cervical cap or menstrual disc to apply numbing cream before IUD placement
This will test whether women getting an IUD can reduce insertion pain by self-applying numbing cream with either a menstrual disc or a cervical cap right before placement.
-
Using TENS units to reduce pain during IUD insertion
This study is testing if using TENS units can help reduce pain for women aged 12 to 50 during IUD insertion.
-
Comparing two types of sutures for vaginal cuff closure in laparoscopic hysterectomy
This study is testing whether a new type of suture can close the vaginal cuff faster than a standard suture for women having laparoscopic hysterectomy, without causing more complications.
-
Registry to collect real-world data on the Cerene Cryotherapy Device
This study is collecting information from women who are using the Cerene Cryotherapy Device to treat heavy menstrual bleeding to see how well it works in real life compared to clinical studies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.