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Desara ® One Single Incision Sling 522 Study

NCT04772131 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-09-19

No results posted yet for this 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

  • Stress Urinary Incontinence

Interventions

DEVICE

Desara® One Single Incision Sling

Single incision sling

DEVICE

Desara® Blue Transobturator Sling

Standard mid-urethral sling

Sponsors & Collaborators

  • Caldera Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04772131 on ClinicalTrials.gov