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Active, not recruiting Not applicable Interventional

Desara ® One Single Incision Sling 522 Study

ClinicalTrials.gov ID: NCT04772131

Public ClinicalTrials.gov record NCT04772131. 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.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 2:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04772131
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Caldera Medical, Inc.
Industry
Enrollment
300 participants

Conditions and interventions

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
Oct 31, 2021
Primary completion
Aug 6, 2026
Completion
Sep 30, 2026
Last update posted
Aug 12, 2026

2021 – 2026

United States locations

U.S. sites
15
U.S. states
14
U.S. cities
15
Facility City State ZIP Site status
Valley Urogynecology Associates, Inc. Phoenix Arizona 85016
University of Arizona College of Medicine Tucson Arizona 85724
Urological Research Center Corp Hialeah Florida 33016
Women's Health Care Associates P.A. dba Rosemark Women Care Specialists Idaho Falls Idaho 83404
CMB Research, LLC Newburgh Indiana 47630
University of Louisville Louisville Kentucky 40202
Mt. Auburn Hospital Division of Urogynecology Cambridge Massachusetts 02138
Specialty Clinical Research of St. Louis, LLC St Louis Missouri 631471
Women's Cancer Center of Nevada Las Vegas Nevada 89169
University of New Mexico Albuquerque New Mexico 87131
Novant Health Urogynecology Charlotte North Carolina 28210
The Lindner Research Center at The Christ Hospital Cincinnati Ohio 45219
Center for Total Women's Health Lansdale Pennsylvania 19446
Center for Pelvic Health Franklin Tennessee 37067
University of Washington Medical Center Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04772131, 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 Aug 12, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04772131 live on ClinicalTrials.gov.

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