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Xenform Postmarket Surveillance Study (Xenform)

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ClinicalTrials.gov Identifier: NCT01945580
Recruitment Status : Active, not recruiting
First Posted : September 18, 2013
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Integra LifeSciences Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE September 15, 2013
First Posted Date  ICMJE September 18, 2013
Last Update Posted Date September 13, 2019
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2013)
Surgical Success [ Time Frame: 36 Months ]
Surgical success will be measured based on anatomic success measures (leading edge of prolapse is at or above the hymen and/or POPQ measurements), no additional surgical treatment for pelvic organ prolapse in the anterior/apical vaginal compartments, and patient denies symptoms of vaginal bulging (per PFDI-20 questionnaire).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01945580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2013)
Incidence of complications [ Time Frame: 36 Months ]
Incidence of mesh erosion, mesh exposure, de novo dyspareunia, and the following device or procedure related events: pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Xenform Postmarket Surveillance Study
Official Title  ICMJE A Prospective, Non-Randomized, Parallel Cohort, Multi-Center Study of Xenform vs. Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse
Brief Summary To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
Detailed Description

The primary objective is to evaluate clinical effectiveness of transvaginal repair with Xenform against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Xenform-related complications and subject reported outcomes.

The primary endpoint of the study is to achieve non-inferiority of transvaginal repair with Xenform over native tissue repair at 36 months as compared to baseline. Success will be based on a composite of objective and subjective measures.

Additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with Xenform to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point.

The secondary endpoints of the study include assessments of complications and subject reported outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Organ Prolapse
Intervention  ICMJE Procedure: Prolapse Repair
Transvaginal anterior/apical pelvic organ prolapse repair
Other Names:
  • Transvaginal
  • Prolapse
  • POP Repair
  • Anterior
  • Apical
Study Arms  ICMJE
  • Active Comparator: Xenform
    Prolapse Repair with Xenform Soft Tissue Repair Matrix
    Intervention: Procedure: Prolapse Repair
  • Active Comparator: Control
    Prolapse Repair with Native Tissue Only
    Intervention: Procedure: Prolapse Repair
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  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 13, 2018)
374
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2013)
454
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is female
  • Subject is at least 18 years of age
  • Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 (for prolapse of the anterior compartment alone) or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments).
  • Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
  • Subject or subject's legally authorized representative is willing to provide written informed consent
  • Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

  • Subject is pregnant or intends to become pregnant during the study
  • Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
  • Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
  • Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
  • Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
  • Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis, polymyalgia rheumatica)
  • Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
  • Subject has uncontrolled diabetes mellitus (DM)
  • Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
  • Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
  • Subject is not able to conform to the modified dorsal lithotomy position
  • Subject is currently participating in or plans to participate in another device or drug study during this study
  • Subject has a known sensitivity to any Xenform component
  • Subject has had previous prolapse repair with mesh in the target compartment
  • Subject is planning to undergo a concomitant prolapse repair with use of mesh in the non-target compartment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01945580
Other Study ID Numbers  ICMJE U9920
AUGS PFD Outcome Registry ( Registry Identifier: AUGS PFD Outcome Registry )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Integra LifeSciences Corporation
Investigators  ICMJE
Principal Investigator: Peter Rosenblatt, MD Mount Auburn Hospital
PRS Account Boston Scientific Corporation
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP