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Feasibility Study of the Reia Vaginal Pessary
NCT04508335 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Reia Vaginal Pessary
Study Locations (7)
Alabama
- University of Alabama at Birmingham — Birmingham
Massachusetts
- Boston Urogynecology Associates — Cambridge
New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon
New York
- New York Medical College — Hawthorne
Pennsylvania
- Main Line Health — Media
Rhode Island
- Women & Infants Hospital — Providence
Texas
- UTHealth — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2021-11-21 |
| Est. Completion | 2023-06-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04508335
The ClinicalTrials.gov registry entry for NCT04508335 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Reia, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 1 intervention — of which Reia Vaginal Pessary is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04508335 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Alabama, Massachusetts, New Hampshire. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04508335 about?
NCT04508335 is a clinical study titled "Feasibility Study of the Reia Vaginal Pessary". 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. Recru...
What is the current status of trial NCT04508335?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2021-11-21. Estimated completion is 2023-06-16.
What conditions does trial NCT04508335 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04508335?
The interventions under investigation include: Reia Vaginal Pessary (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04508335?
This trial is sponsored by Reia, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04508335 being conducted?
This trial has 7 study locations across Alabama, Massachusetts, New Hampshire, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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