Early Feasibility Study of the Reia Vaginal Pessary

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04275089
Study type	Interventional
Source	Reia, LLC
Contact
Status	Completed
Phase	N/A
Start date	November 5, 2020
Completion date	January 20, 2021

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