COMPLETED

Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-09
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06193590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Age 18 years or older
  2. * Speaks and reads in English
  3. * Able to consent on their own
  4. * Will undergo any intrauterine procedure using the Carevix (for exposure group) or using Tenaculum (for Control Group)
  5. * Cervix at least 26 mm in diameter
  6. * Twenty providers performing this procedure
  1. * • Vaginal bleeding of unknown origin
  2. * Cervix less than 26 mm in diameter
  3. * Nabothian cyst on anterior lip of cervix
  4. * Cervical myomas
  5. * Cervical abnormalities
  6. * Pregnant

Contacts and Locations

Principal Investigator

Alissa Conklin, MD
PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine

Study Locations (Sites)

Indiana University Hospital
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Alissa Conklin, MD, PRINCIPAL_INVESTIGATOR, Indiana University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-09
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2023-11-09
Study Completion Date2024-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Intrauterine Device (IUD)
  • Abnormal Uterine Bleeding