Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study

This study is currently recruiting participants.
Verified February 2014 by Coloplast A/S
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01541748
First received: February 17, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.


Condition Intervention
Pelvic Organ Prolapse
Other: Axis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Evaluate efficacy of the Axis Dermis graft used for soft tissue repair, replacement, reconstruction, or augmentations in the correction of POP as assessed by POP-Q Stage improvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess change in prolapse stage from baseline [ Time Frame: 6 weeks, 6 months, 2 years, 3 years ] [ Designated as safety issue: No ]
    Determined by POP-Q prolapse grading

  • Patient satisfaction and quality of life measurement [ Time Frame: 6 weeks, 6 months, 2 years, 3 years ] [ Designated as safety issue: No ]
    Measured through patient questionnaires PFDI-20, PFIQ-7, PISQ-12, PGI-I, SSQ-8, and Pelvic and Sexual Health VAS

  • Summary of AEs graded as mild, moderate, severe possibly or related to product and/or procedure and SAEs related to product and/or procedure [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Axis Other: Axis
Coloplast's Axis™ Allograft Dermis consists of solvent-dehydrated, gamma-irradiated, preserved human collagen. It is restricted to homologus use as a soft tissue graft for horizontal and vertical soft tissue augmentation of thickness and length.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult female at least 18 years of age.
  • Willing and able to provide written informed consent.
  • Confirmed pelvic organ prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading requiring surgical intervention in the anterior, posterior or combined (anterior and posterior) compartment.
  • Willing and able to complete all follow-up visits and procedures indicated in this protocol.

Exclusion Criteria:

  • Concurrent surgical treatment of pelvic organ prolapse using anything other than the Axis Dermis.[Note: concurrent mid-urethral sling placement for treatment of stress urinary incontinence is allowed].
  • Confirmed Stage 2 or higher prolapse as determined by POP-Q prolapse grading for a compartment that is not being repaired in the same procedure. (Concurrent POP-Q Stage 1 repair is at the physician's discretion.)
  • Previous pelvic organ prolapse repair using biologic, or synthetic grafts. [Note: previous midurethral sling for treatment of stress urinary incontinence is allowed]
  • Pregnant or a desire to become pregnant in the future.
  • Previous radiation or other treatments for cancer in the pelvic area.
  • Severe urogenital atrophy.
  • Immunosuppression and/or current systemic steroid user.
  • Any contraindication to the surgical procedure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541748

Contacts
Contact: Dale Klous 612-302-4997 usdkl@coloplast.com

Locations
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Calvin Killingbeck    954-659-6247      
Principal Investigator: G Willy Davila, MD         
United States, Massachusetts
Boston Urogynecology Associates Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Kathleen Rogers    617-354-5452      
Principal Investigator: Peter Rosenblatt, MD         
United States, Michigan
Female Pelvic Medicine and Urogynecology Institute of MI Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Beth Rogers, RN    616-588-1135    brogers@grwh.org   
Principal Investigator: Douglas Van Drie, MD         
United States, Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Tracy Butryn, MS    484-526-5190    Tracy.Butryn@sluhn.org   
Principal Investigator: Vincent Lucente, MD         
Philadelphia Urosurgical Associates Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Elizabeth Elias, CCRP    267-479-2387    elias.pashi@yahoo.com   
Principal Investigator: Kristine Whitmore, MD         
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Kristine Whitmore, MD Philadelphia Urosurgical Associates
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01541748     History of Changes
Other Study ID Numbers: CP009SU
Study First Received: February 17, 2012
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014