Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Indiana University

Status: Completed

Conditions: Intrauterine Device (IUD); Abnormal Uterine Bleeding

Treatments: Device: Tenaculum; Device: Carevix

Study type: Interventional

Funder types: Other

Identifiers

NCT06193590

19699

Details and patient eligibility

About

To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Age 18 years or older

  • Speaks and reads in English
  • Able to consent on their own
  • Will undergo any intrauterine procedure using the Carevix (for exposure group) or using Tenaculum (for Control Group)
  • Cervix at least 26 mm in diameter
  • Twenty providers performing this procedure

Exclusion criteria

• • Vaginal bleeding of unknown origin

  • Cervix less than 26 mm in diameter
  • Nabothian cyst on anterior lip of cervix
  • Cervical myomas
  • Cervical abnormalities
  • Pregnant

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Carevix

Experimental group

Description:

suction cervical stabilizer utilized for intrauterine procedures

Treatment:

Device: Carevix

Tenaculum

Active Comparator group

Description:

standard of care cervical stabilization device

Treatment:

Device: Tenaculum