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NCT04508335 · ClinicalTrials.gov registry record · NA
Feasibility Study of the Reia Vaginal Pessary
A NA study of Pelvic Organ Prolapse, sponsored by Reia.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 7
- Study locations
NCT04508335 is a NA study of Pelvic Organ Prolapse that has completed, run by Reia. The registered enrollment target is 78 participants, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (45% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT04508335, a NA study of Pelvic Organ Prolapse, has completed, sponsored by Reia.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 7
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (45% lower). The listed sponsor is Reia, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT04508335 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Alabama, Massachusetts, New Hampshire.
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.
What interventions are being tested in trial NCT04508335?
The interventions under investigation include: Reia Vaginal Pessary (DEVICE).
Who is sponsoring clinical trial NCT04508335?
This trial is sponsored by Reia, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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