NCT04275089

Early Feasibility Study of the Reia Vaginal Pessary

Early Feasibility Prospective Open-Label Study to Assess the Function of a Novel Pessary for the Non-Surgical Management of Pelvic Organ Prolapse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Reia, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse (POP). Recruited patients will have Stage II POP or greater and will be current users of a legally marketed vaginal pessary. In a single visit, data will be collected on the performance and comfort of the subject's current pessary. After placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. The study pessary's function will be assessed under controlled circumstances. The patient will have her current pessary replaced at the conclusion of the visit. Results will be used to inform future design modifications of the study pessary.

Conditions

• Pelvic Organ Prolapse
• Prolapse

Interventions

Type	Name	Description
DEVICE	Reia Vaginal Pessary	Reia Vaginal Pessary

Timeline

• Start date: 2020-11-05
• Primary completion: 2021-01-20
• Completion: 2021-01-20
• First posted: 2020-02-19
• Last updated: 2023-07-28
• Results posted: 2023-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study