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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: Completed NA study, sponsored by Reia.
NCT04275089 is a NA study that has completed, run by Reia. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The subject will be asked to Valsalva with their current pessary in place, and the distance from the leading edge of the current pessary to the hymen will be measured in centimeters. After the current pessary is removed and with the study pessary in place, the subject will be asked to Valsalva again. The distance from the leading edge of the study pessary to the hymen will be measured in centimeters. In order to assess the ability of the study pessary to function and be retained, the measurement
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 |
What the finished NCT04275089 record still lists
NCT04275089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Reia Vaginal Pessary is the first listed.
NCT04275089 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04275089's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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