Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
This study is currently recruiting participants.
Verified March 2013 by Coloplast A/S
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01541748
First received: February 17, 2012
Last updated: March 12, 2013
Last verified: March 2013
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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: 3 years ] [ Designated as safety issue: No ]Determined by POP-Q prolapse grading
- Patient satisfaction and quality of life measurement [ Time Frame: 3 years ] [ Designated as safety issue: No ]Measured through patient quality of life questionnaires PFDI-20,PFIQ-12, PGi-I,SSQ-8
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: POP Treatment |
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
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, 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: Robin Haff, RN, BSN 610-435-9575 ext 111 Haffr@slhn.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: | March 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 18, 2013