Status: Recruiting
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.
Participants needed: 300
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Caldera Medical, Inc.Updated: Sep 19, 2025Locations: 15
Eligibility criteria
Female ≥ 18 of age. [+10]
Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS). [+24]