NCT06193590

Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intrauterine Device (IUD)
• Abnormal Uterine Bleeding

Interventions

Type	Name	Description
DEVICE	Carevix	Cervical stabilization device that uses vacuum
DEVICE	Tenaculum	standard of care cervical stabilization device

Timeline

• Start date: 2023-11-09
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2024-01-05
• Last updated: 2025-06-10
• Results posted: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study