Desara ® One Single Incision Sling 522 Study
Recruiting
N/A
Interventional Study
Stress Urinary Incontinence
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Caldera Medical, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Female ≥ 18 of age.
2. Subject agrees that she is willing and able to return for all study related procedures and evaluations.
3. Subject has provided signed informed consent.
4. Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress…
Contacts