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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 11, 2014
Last verified: September 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
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: 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: Eileen Taff, MSN, RN    610-435-9575 ext 103    ETaff@fpminstitute.com   
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: September 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014