Soft Tissue Graft for Repair of Pelvic Organ Prolapse

Overview

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.

Full Title of Study: “A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 17, 2017

Interventions

  • Device: Surgisis® Soft Tissue Graft
    • Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

Arms, Groups and Cohorts

  • Experimental: Surgisis® Soft Tissue Graft

Clinical Trial Outcome Measures

Primary Measures

  • Rate of recurrence of pelvic organ prolapse
    • Time Frame: 12 months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cook Group Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor

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