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NCT04275089 · ClinicalTrials.gov registry record · NA
Early Feasibility Study of the Reia Vaginal Pessary
A NA study, sponsored by Reia.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT04275089 is a NA study that has completed, run by Reia. The registered enrollment target is 15 participants.
The verdict
NCT04275089, a NA study, has completed, sponsored by Reia.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Reia Vaginal Pessary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-11-05 |
| Est. Completion | 2021-01-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04275089
The ClinicalTrials.gov registry entry for NCT04275089 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Reia, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Reia Vaginal Pessary is the first listed.
NCT04275089 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04275089 about?
NCT04275089 is a clinical study titled "Early Feasibility Study of the Reia Vaginal Pessary". 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 b...
What is the current status of trial NCT04275089?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2020-11-05. Estimated completion is 2021-01-20.
What interventions are being tested in trial NCT04275089?
The interventions under investigation include: Reia Vaginal Pessary (DEVICE).
Who is sponsoring clinical trial NCT04275089?
This trial is sponsored by Reia, which has 2 total clinical trials registered on ClinicalTrials.gov.
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