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

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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.


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
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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Cambridge, MA
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Grand Rapids, MI
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Philadelphia, Pennsylvania 19107
Principal Investigator: Kristine Whitmore, MD
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Philadelphia, PA
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