Recruiting

Carevix vs. Tenaculum

Sponsor:

Indiana University

Code:

NCT07290517

Conditions

IUD

Abnormal Uterine Bleeding

Pain, Cervical

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carevix

Tenaculum

Study Details

Brief 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

Conditions

IUD

Abnormal Uterine Bleeding

Pain, Cervical

Study ID

NCT07290517

Start date

Mar 11, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Carevix

Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion.

active comparator: Tenaculum

Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion.

Interventions

Carevix

Vacuum cervical stabilization device

Tenaculum

Standard of care cervical stabilization device

Primary outcome measure

  • Patient pain score [ Time Frame: During Procedure (at Cervix Grasping, at Cervix Traction, and at IUD placement) ]
  • Difference in Pain Score [ Time Frame: Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion ]
  • Highest Pain Score [ Time Frame: Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion ]
  • Expectation of Pain [ Time Frame: Within 15 minutes after IUD procedure completion ]

Central Contacts and Locations

Central contacts

Alissa M Conklin, MD

317-944-8231alconkli@iu.edu

Kylie L Williams, MA

kylowill@iu.edu

Locations

Indiana University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Alissa M Conklin, MD

317-944-8231alconkli@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 13, 2026

Last verified

Jun, 2026

Keywords

  • IUD insertion
  • Cervical Stabilization
  • Tenaculum
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-13.