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

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ClinicalTrials.gov Identifier: NCT01541748
Recruitment Status : Active, not recruiting
First Posted : March 1, 2012
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
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 or disease Intervention/treatment
Pelvic Organ Prolapse Other: Axis

Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Study Start Date : November 2011
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assess change in prolapse stage from baseline [ Time Frame: 6 weeks, 6 months, 2 years, 3 years ]
    Determined by POP-Q prolapse grading

  2. Patient satisfaction and quality of life measurement [ Time Frame: 6 weeks, 6 months, 2 years, 3 years ]
    Measured through patient questionnaires PFDI-20, PFIQ-7, PISQ-12, PGI-I, SSQ-8, and Pelvic and Sexual Health VAS

  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis human tissue in the anterior, posterior, or combined (anterior and posterior) compartments at the institutions designated for this study.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541748


Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Massachusetts
Boston Urogynecology Associates
Cambridge, Massachusetts, United States, 02138
United States, Michigan
Female Pelvic Medicine and Urogynecology Institute of MI/Grand Rapids Women's Health
Grand Rapids, Michigan, United States, 49503
United States, Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103
Philadelphia Urosurgical Associates
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Kristine Whitmore, MD Philadelphia Urosurgical Associates

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01541748     History of Changes
Other Study ID Numbers: CP009SU
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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