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OpenTrials
Completed

NCT Number: NCT06193590

Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

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.

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Key information

Conditions

Intrauterine Device (IUD) Abnormal Uterine Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carevix

Device

Cervical stabilization device that uses vacuum

Tenaculum

Device

standard of care cervical stabilization device

Primary outcomes

  1. Patient-perceived Pain

    Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

    Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded.

Secondary outcomes

  1. Provider-perceived Bleeding

    Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

    Bleeding perceived by the provider during and after the procedure.

  2. Provider-perceived Ease of Use

    Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

    Providers will report their perceived ease of use with the Carevix device indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response.

  3. Provider-perceived Satisfaction

    Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

    Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Safety and Efficacy of a Suction Cervical Stabilizer Compared to the Standard Tenaculum for Intrauterine Procedures in the Clinic Setting

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2024
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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