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Trial record 4 of 79 for:    Open Studies | "Pelvic Organ Prolapse"

Soft Tissue Graft for Repair of Pelvic Organ Prolapse (POP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01827774
First received: April 3, 2013
Last updated: November 25, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Device: Surgisis® Soft Tissue Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Rate of recurrence of pelvic organ prolapse [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: March 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgisis® Soft Tissue Graft Device: Surgisis® Soft Tissue Graft
Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827774

Contacts
Contact: Tony Wang +86-10-6563-3366 ext 2300 Tony.Wang@CookMedical.com

Locations
China
Peking University People's Hospital Recruiting
Beijing, China, 100044
Contact: Xiuli SUN    +86-18611661856    sunxiuli918@126.com   
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01827774     History of Changes
Other Study ID Numbers: 12-015
Study First Received: April 3, 2013
Last Updated: November 25, 2014
Health Authority: China: Ethics Committee

Keywords provided by Cook:
Pelvic organ prolapse
Graft repair

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014