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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06193590
Other study ID # 19699
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2023
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source Indiana University
Contact Kylie L Williams, MA
Phone 317-948-7064
Email kylowill@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Carevix
Cervical stabilization device that uses vacuum
Tenaculum
standard of care cervical stabilization device

Locations

Country Name City State
United States Indiana University Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yaron M, Legardeur H, Barcellini B, Akhoundova F, Mathevet P. Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study. Contraception. 2023 Jul;123:110004. doi: 10.1016/j.contraception.2023.110004. Epub 2023 Mar 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-perceived pain Patients will be asked to rate their pain on a 10 point Likert scale. Lower numbers represent lower pain. Upon cervical stabilization, and immediately after intrauterine procedure is complete
Secondary Provider-perceived bleeding Bleeding perceived by the provider during and after the procedure Immediately after intrauterine procedure is complete
Secondary Provider-perceived ease of use Providers will report their perceived ease of use indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. Immediately after intrauterine procedure is complete
Secondary Provider-perceived satisfaction Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. Immediately after intrauterine procedure is complete
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