Restorelle® Mesh Versus Native Tissue Repair for Prolapse
Public ClinicalTrials.gov record NCT02162615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.
Study identification
- NCT ID
- NCT02162615
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 810 participants
Conditions and interventions
Conditions
Interventions
- Restorelle Direct Fix A Device
- Restorelle Direct Fix P Device
- Native Tissue Repair Anterior Procedure
- Native Tissue Repair Posterior Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2014 (Actual)
- Primary completion
- Jan 15, 2020 (Actual)
- Completion
- Nov 6, 2021 (Actual)
- Last update posted
- Jan 27, 2022
2014 – 2021
United States locations
- U.S. sites
- 33
- U.S. states
- 20
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sherry Thomas, M.D. | Agoura Hills | California | 91301 | — |
| Stanford University | Stanford | California | 94305 | — |
| SurgOne Pelvic Solutions Center | Denver | Colorado | 80218 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| Center for Urogynecology and Pelvic Surgery, Christiana Care Health System | Newark | Delaware | 19713 | — |
| MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery | Washington D.C. | District of Columbia | 20010 | — |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | — |
| Andrew Shapiro | Owings Mills | Maryland | 21117 | — |
| Baystate Health System | Springfield | Massachusetts | 01199 | — |
| Female Pelvic Medicine & Urogynecology Institute of MI | Grand Rapids | Michigan | 49503 | — |
| Beyer Research | Kalamazoo | Michigan | 49009 | — |
| Adult & Pediatric Urology, PC | Omaha | Nebraska | 68114 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| Atlantic Health System | Morristown | New Jersey | 07960 | — |
| Premier Medical Group of Hudson Valley, PC | Poughkeepsie | New York | 12601 | — |
| Montefiore Medical Research Center | The Bronx | New York | 10461 | — |
| Novant Health Urogynecology | Charlotte | North Carolina | 28210 | — |
| Women's Pelvic Health and Continence Center | Hamlet | North Carolina | 28345 | — |
| Novant Health Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Akron Urogynecology Associates | Akron | Ohio | 44333 | — |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | 18103 | — |
| Center for Women's Health of Lansdale | Lansdale | Pennsylvania | 19446 | — |
| The Female Pelvic Health Center | Newtown | Pennsylvania | 18940 | — |
| Wellspan Urogynecology and Pelvic Reconstructive Surgery | York | Pennsylvania | 17403 | — |
| Sanford Research | Sioux Falls | South Dakota | 57104 | — |
| Swan Urogynecology | Nashville | Tennessee | 37203 | — |
| Central Texas Urogynecology and Continence Center | Austin | Texas | 78758 | — |
| Scott D. Lauer, DO, PA | Colleyville | Texas | 76034 | — |
| Carilion Clinic New River Valley | Christiansburg | Virginia | 24073 | — |
| The Group for Women | Norfolk | Virginia | 23502 | — |
| Integrity Medical Research | Mountlake Terrace | Washington | 98042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02162615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02162615 live on ClinicalTrials.gov.