Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance (SPARO)

Distalmotion

Status: Enrolling

Conditions: Sacrocolpopexy

Treatments: Device: sacrocolpopexy or sacrocervicopexy

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07031050

2024-03

Details and patient eligibility

About

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted sacrocolpopexy or sacrocervicopexy.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged > 18 years
• Women with symptomatic stage I or greater pelvic organ prolapse (POP-Q)
• Patient agrees to perform the 6-week follow-up assessment as per Standard of Care

Exclusion criteria

• Any planned non-urogynaecological concomitant procedures
• History of previous POP surgery, with the exception of transvaginal approaches without mesh implantation
• Previous surgery and/or radiation for urologic, gastrointestinal or gynecologic cancer
• History of Crohn's disease
• Chronic colitis