Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Status: | Active, not recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/26/2018 |
Start Date: | November 2011 |
End Date: | December 30, 2018 |
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.
efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and
posterior) pelvic organ prolapse repair.
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.
We found this trial at
5
sites
Allentown, Pennsylvania 18105
Principal Investigator: Vincent Lucente, MD
Phone: 610-435-9575
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
Weston, Florida 33331
866.293.7866
Principal Investigator: G Willy Davila, MD
Phone: 954-659-6247
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Cambridge, Massachusetts 02138
Principal Investigator: Peter Rosenblatt, MD
Phone: 617-354-5452
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Grand Rapids, Michigan 49503
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Philadelphia, Pennsylvania 19107
Principal Investigator: Kristine Whitmore, MD
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