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NCT06634459 · ClinicalTrials.gov registry record · NA
POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
A NA study of Pelvic Organ Prolapse and Prolapse, sponsored by Medstar Health Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 182
- Enrollment target
- 9
- Study locations
NCT06634459 is a NA study of Pelvic Organ Prolapse and Prolapse that is actively recruiting participants, run by Medstar Health Research Institute. The registered enrollment target is 182 participants, above the 141-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (29% higher). The trial reports 9 study locations across 9 states.
The verdict
NCT06634459, a NA study of Pelvic Organ Prolapse and Prolapse, is actively recruiting participants, sponsored by Medstar Health Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
- 9
- Study locations
Study Summary
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 182 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events. Specific Aims Aim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 3: To compare ease/difficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those
Conditions Studied
Interventions
- DEVICE Reia System
- DEVICE Standard of Care Pessary
Study Locations (9)
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Stanford University - Palo Alto
District of Columbia
- MedStar Health - Washington D.C.
Illinois
- The University of Chicago - Northbrook
New Hampshire
- Dartmouth-Hitchcock - Lebanon
New Mexico
- University of New Mexico Health Sciences Center - Albuquerque
North Carolina
- Atrium Health Wake Forest Baptist - Winston-Salem
Rhode Island
- Women & Infants Hospital in Rhode Island - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2026-10-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06634459
The ClinicalTrials.gov registry entry for NCT06634459 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 141-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (29% higher). The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions - of which Reia System is the first listed.
NCT06634459 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Alabama, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06634459 about?
NCT06634459 is a clinical study titled "POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment". This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic...
What is the current status of trial NCT06634459?
This trial is currently recruiting. It is a NA study. The enrollment target is 182 participants. The study started on 2024-11-01. Estimated completion is 2026-10-30.
What conditions does trial NCT06634459 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse, Prolapse.
What interventions are being tested in trial NCT06634459?
The interventions under investigation include: Reia System (DEVICE), Standard of Care Pessary (DEVICE).
Who is sponsoring clinical trial NCT06634459?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06634459 being conducted?
This trial has 9 study locations across Alabama, California, District of Columbia, Illinois, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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