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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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06193590
Study type Interventional
Source Indiana University
Contact Kylie L Williams, MA
Phone 317-948-7064
Email kylowill@iu.edu
Status Recruiting
Phase N/A
Start date November 9, 2023
Completion date June 30, 2024
View Details
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