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POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
NCT06634459 · View on ClinicalTrials.gov ↗
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 |
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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. 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 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 130 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT06634459 reports 9 study locations spanning 9 distinct geographic areas — top geographies include Alabama, California, District of Columbia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06634459?
The interventions under investigation include: Reia System (DEVICE), Standard of Care Pessary (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06634459?
This trial is sponsored by Medstar Health Research Institute, which has 130 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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