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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01541748
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Tracking Information
First Submitted Date February 17, 2012
First Posted Date March 1, 2012
Last Update Posted Date July 23, 2019
Study Start Date November 2011
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2012)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 25, 2013)
  • Assess change in prolapse stage from baseline [ Time Frame: 6 weeks, 6 months, 2 years, 3 years ]
    Determined by POP-Q prolapse grading
  • 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
  • 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 ]
Original Secondary Outcome Measures
 (submitted: February 24, 2012)
Secondary objectives will assess POP-Q Stage and patient satisfaction at each follow-up visit [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Official Title Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pelvic Organ Prolapse
Intervention 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.
Study Groups/Cohorts Axis
Intervention: Other: Axis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 28, 2016)
74
Original Estimated Enrollment
 (submitted: February 24, 2012)
100
Actual Study Completion Date November 28, 2018
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01541748
Other Study ID Numbers CP009SU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Coloplast A/S
Study Sponsor Coloplast A/S
Collaborators Not Provided
Investigators
Principal Investigator: Kristine Whitmore, MD Philadelphia Urosurgical Associates
PRS Account Coloplast A/S
Verification Date July 2019