Study of the Elevate Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse (Embrace)

A Prospective, Safety and Efficacy Cohort Study of Elevate® Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair

The aim of this study is to further evaluate the safety and efficacy of the Elevate® Anterior and Apical Prolapse Repair System for repair of anterior/apical pelvic organ prolapse in a controlled, post-market cohort study.

Study Overview

• Status: Terminated
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Native Tissue Repair for pelvic organ prolapse; Device: Elevate Anterior and Apical

Detailed Description

The Embrace 522 study has been terminated due to the closing of the Astora Women's Health business. No other entity will be taking responsibility for this study. The study was terminated with partial subject enrollment complete and therefore no primary or secondary data analysis can be performed. The data from this study resides in a national data base which Astora no longer has access and therefore is another reason why no data analysis can be performed. The national database is owned and managed by the American Urogynecology Society (AUGS). AUGS has access to Astora's data and will at some time in the near future publish results to physicians who are active participants in the registry. Full public disclosure of this data may not occur for a number of years and will be aggregated with data from other study sponsors.

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85941
      • Urological Associates of Southern Arizona
  • California
    • Beverly Hills, California, United States, 21202
      • Cedars-Sinai Medical Group
    • Newport Beach, California, United States, 92663
      • The Clark Center for Urogynecology
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • National Center for Advanced Pelvic Surgery
  • Florida
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Women's Health Advantage
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Weinberg Center for Women's Health and Medicine
    • Owings Mills, Maryland, United States, 21117
      • Chesapeake Urology
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health System
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Metro Urology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult & Pediatric Urology and Urogynecology
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Women's Cancer Center of Nevada
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Urogynecology & Pelvic Reconstructive Surgery - Atlantic Health System
    • Princeton, New Jersey, United States, 8540
      • Princeton Medical Center
    • Turnersville, New Jersey, United States, 08012
      • Athena Women's Institute for Pelvic Health
    • Whippany, New Jersey, United States, 07981
      • The Center for Specialized Women's Health
  • New York
    • Great Neck, New York, United States, 11021
      • North Shore Women's Health Clinic
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group
  • Ohio
    • Cincinnati,, Ohio, United States, 45242
      • Seven Hills Woman's Health Center
    • West Chester, Ohio, United States, 45069
      • The Christ Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • The Institute for Female Pelvic Medicine - St. Luke's Hospital
    • Lansdale, Pennsylvania, United States, 19446
      • Center for Women's Health of Lansdale
    • Newtown, Pennsylvania, United States, 18940
      • The Female Pelvic Health Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Swan Urogynecology
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas at Galveston
    • Round Rock, Texas, United States, 78665
      • Lone Star Urogynecology and Continence Center
  • Virginia
    • North Chesterfield, Virginia, United States, 23235
      • Female Pelvic Medicine Institute of Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology Of Virginia, Pllc
  • Washington
    • Issaquah, Washington, United States, 98027
      • Athena Women's Health
    • Seattle, Washington, United States, 98195
      • University of Washington Pelvic Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Subject is female Subject is at least 18 years of age

Subject must have documented diagnosis of anterior or anterior and apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥ 0; or Ba ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment anterior prolapse that includes the apical compartment)

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, or cervical)

Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, 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's syndrome, Ehlers Danhlos, collagenosis, polymyositis or 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 polypropylene

Subject has had previous prolapse repair with mesh in the target compartment

Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Elevate Anterior and Apical; Prolapse repair with mesh	Device: Elevate Anterior and Apical
Active Comparator: Native Tissue Repair; Prolapse repair with sutures	Procedure: Native Tissue Repair for pelvic organ prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures	36 months
Rate of device or procedure related serious adverse events	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures	36 months
Rate of repeat surgery/revision for prolapse arising from the same site/target compartment	36 months
Changes in Quality of Life measured through the following questionaires: PFDI-20,PFIQ-7, PISQ-12	36 months

Other Outcome Measures

Outcome Measure	Time Frame
Subjects experiencing vaginal bulge	36 months
Subjects experiencing adverse events related to device or procedure	36 months
Subjects experiencing prolapse at or beyond the hymenal ring	36 months

Collaborators and Investigators

• Sponsor: ASTORA Women's Health
• Investigators: Principal Investigator: Eric R Sokol, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 24, 2014

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PR1205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES