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Desara ® One Single Incision Sling 522 Study
NCT04772131 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04772131
The ClinicalTrials.gov registry entry for NCT04772131 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 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Caldera Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT04772131 reports 15 study locations spanning 14 distinct geographic areas — top geographies include Arizona, Florida, Idaho. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04772131?
The interventions under investigation include: Desara® One Single Incision Sling (DEVICE), Desara® Blue Transobturator Sling (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04772131?
This trial is sponsored by Caldera Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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