Soft Tissue Graft for Repair of Pelvic Organ Prolapse

NCT01827774 | Completed

• 1 other identifier: 12-015
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

Pelvic organ prolapse; Graft repair

Outcome Measures

Primary Outcomes (1)

• Rate of recurrence of pelvic organ prolapse

  12 months

Study Arms (1)

Surgisis® Soft Tissue Graft

EXPERIMENTAL

Device: Surgisis® Soft Tissue Graft

Interventions

Surgisis® Soft Tissue Graft DEVICE

Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

Surgisis® Soft Tissue Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook Group Incorporated: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 10, 2013
• Study Start: March 1, 2013
• Primary Completion: April 17, 2017
• Study Completion: April 17, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

CN (1)