Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Abnormal Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193590
• Other study ID #: 19699
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Uterine Hemorrhage

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

External Links

•   journal article