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NCT04772131 · ClinicalTrials.gov registry record · NA
Desara ® One Single Incision Sling 522 Study
A NA study of Stress Urinary Incontinence, sponsored by Caldera Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 15
- Study locations
NCT04772131: Recruiting NA study of Stress Urinary Incontinence, sponsored by Caldera Medical.
NCT04772131 is a NA study of Stress Urinary Incontinence that is actively recruiting participants, run by Caldera Medical. The registered enrollment target is 300 participants, above the 154-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (95% higher). The trial reports 15 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04772131, a NA study of Stress Urinary Incontinence, is actively recruiting participants, sponsored by Caldera Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 15
- Study locations
Study Summary
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
Primary Outcome
Negative standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound, evaluated at the 36-month post-implant follow-up visit. The success rate is defined as the proportion of subjects with a negative CST at the 36-month post-implant follow-up
Conditions Studied
Interventions
- DEVICE Desara® One Single Incision Sling
- DEVICE Desara® Blue Transobturator Sling
Study Locations (15)
Arizona
- Valley Urogynecology Associates, Inc. - Phoenix
- University of Arizona College of Medicine - Tucson
Florida
- Urological Research Center Corp - Hialeah
Idaho
- Women's Health Care Associates P.A. dba Rosemark Women Care Specialists - Idaho Falls
Indiana
- CMB Research, LLC - Newburgh
Kentucky
- University of Louisville - Louisville
Massachusetts
- Mt. Auburn Hospital Division of Urogynecology - Cambridge
Missouri
- Specialty Clinical Research of St. Louis, LLC - St Louis
Nevada
- Women's Cancer Center of Nevada - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2026-11 |
| Phase | NA |
What NCT04772131 shows while recruiting
NCT04772131 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (95% higher).
The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Desara® One Single Incision Sling is the first listed.
NCT04772131 lists 15 locations in 14 states (Arizona, Florida, Idaho).
Frequently Asked Questions
What is clinical trial NCT04772131 about?
NCT04772131 is a clinical study titled "Desara ® One Single Incision Sling 522 Study". A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
What is the current status of trial NCT04772131?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2021-11-01. Estimated completion is 2026-11.
What conditions does trial NCT04772131 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence.
What interventions are being tested in trial NCT04772131?
The interventions under investigation include: Desara® One Single Incision Sling (DEVICE), Desara® Blue Transobturator Sling (DEVICE).
Who is sponsoring clinical trial NCT04772131?
This trial is sponsored by Caldera Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04772131 being conducted?
This trial has 15 study locations across Arizona, Florida, Idaho, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress Urinary Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04772131's enrollment target sits among peer trials
300 6th of 35 higher than 30 of 35 other Stress Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Urinary Incontinence 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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