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Clinical trialNCT04508335CompletedInterventional

Feasibility Study of the Reia Vaginal Pessary

SponsorReia, LLCEnrollment78Pelvic Organ Prolapse
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ prolapse (POP) and have already opted for non-surgical management. Recruited patients will have Stage II POP or greater and will be current users of a Gellhorn or ring style pessary. Following enrollment, each subject will enter a 1-month wash out period in which they will continue using their current pessary so that baseline subjective and objective data can be collected. They will then be fit with a study pessary and enter a 3-month treatment phase. Comparative, subjective, and objective data will be collected at the conclusion of the study.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • Boston Urogynecology Associates

    Cambridge, Massachusetts, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, United States

  • New York Medical College

    Hawthorne, New York, United States

  • Main Line Health

    Media, Pennsylvania, United States

  • Women & Infants Hospital

    Providence, Rhode Island, United States

  • Uthealth

    Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
21 Nov 2021
Primary completion
16 Jun 2023
Completion
16 Jun 2023
Last update posted
27 Nov 2024
Registered enrollment
78
Registry id
NCT04508335

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.