Soft Tissue Graft for Repair of Pelvic Organ Prolapse

NCT ID: NCT01827774

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-04-17

Brief Summary

The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgisis® Soft Tissue Graft

Group Type: EXPERIMENTAL

Surgisis® Soft Tissue Graft

Intervention Type: DEVICE

Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

Interventions

Surgisis® Soft Tissue Graft

Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse.
• POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse)
• At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia)

Exclusion Criteria

• Age < 18 years
• BMI > 40
• Not medically fit for transvaginal surgery under general or spinal anesthesia
• Active UTI at the time of the index procedure as determined by urine culture
• Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.)
• Prior placement of synthetic mesh or biologic graft for pelvic organ prolapse
• A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer
• Currently planned obliterative surgical repair for pelvic organ prolapse
• Systemic infection at the time of surgery
• Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents
• Pregnant, breastfeeding or planning pregnancy during the study period
• Previous diagnosis of collagen disorder (i.e., Marfan's, Ehlers-Danlos)
• Physical allergies or cultural objections to the receipt of porcine products
• Life expectancy of less than 12 months
• Ongoing participation in an investigational device or drug trial
• Currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome)
• Active vaginal infection at the time of the index procedure
• History of pelvic inflammatory disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cook Group Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

Other Identifiers

12-015

Identifier Type: -

Identifier Source: org_study_id