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

Primary Purpose

Pelvic Organ Prolapse

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Elevate Anterior and Apical
Native Tissue Repair for pelvic organ prolapse
Sponsored by
ASTORA Women's Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urological Associates of Southern Arizona
  • Cedars-Sinai Medical Group
  • The Clark Center for Urogynecology
  • Yale School of Medicine
  • National Center for Advanced Pelvic Surgery
  • East Coast Institute for Research, LLC
  • Women's Health Advantage
  • Weinberg Center for Women's Health and Medicine
  • Chesapeake Urology
  • Beaumont Health System
  • Metro Urology
  • Adult & Pediatric Urology and Urogynecology
  • Women's Cancer Center of Nevada
  • Urogynecology & Pelvic Reconstructive Surgery - Atlantic Health System
  • Princeton Medical Center
  • Athena Women's Institute for Pelvic Health
  • The Center for Specialized Women's Health
  • North Shore Women's Health Clinic
  • Premier Medical Group
  • Seven Hills Woman's Health Center
  • The Christ Hospital
  • The Institute for Female Pelvic Medicine - St. Luke's Hospital
  • Center for Women's Health of Lansdale
  • The Female Pelvic Health Center
  • Swan Urogynecology
  • University of Texas at Galveston
  • Lone Star Urogynecology and Continence Center
  • Female Pelvic Medicine Institute of Virginia
  • Urology of Virginia, PLLC
  • Athena Women's Health
  • University of Washington Pelvic Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Elevate Anterior and Apical

Native Tissue Repair

Arm Description

Prolapse repair with mesh

Prolapse repair with sutures

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2014
Last Updated
September 6, 2016
Sponsor
ASTORA Women's Health
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1. Study Identification

Unique Protocol Identification Number
NCT02121977
Brief Title
Study of the Elevate Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
Acronym
Embrace
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Astora business is closing
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ASTORA Women's Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elevate Anterior and Apical
Arm Type
Active Comparator
Arm Description
Prolapse repair with mesh
Arm Title
Native Tissue Repair
Arm Type
Active Comparator
Arm Description
Prolapse repair with sutures
Intervention Type
Device
Intervention Name(s)
Elevate Anterior and Apical
Intervention Type
Procedure
Intervention Name(s)
Native Tissue Repair for pelvic organ prolapse
Primary Outcome Measure Information:
Title
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures
Time Frame
36 months
Title
Rate of device or procedure related serious adverse events
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures
Time Frame
36 months
Title
Rate of repeat surgery/revision for prolapse arising from the same site/target compartment
Time Frame
36 months
Title
Changes in Quality of Life measured through the following questionaires: PFDI-20,PFIQ-7, PISQ-12
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Subjects experiencing adverse events related to device or procedure
Time Frame
36 months
Title
Subjects experiencing vaginal bulge
Time Frame
36 months
Title
Subjects experiencing prolapse at or beyond the hymenal ring
Time Frame
36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric R Sokol, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urological Associates of Southern Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85941
Country
United States
Facility Name
Cedars-Sinai Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
21202
Country
United States
Facility Name
The Clark Center for Urogynecology
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
National Center for Advanced Pelvic Surgery
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Women's Health Advantage
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Weinberg Center for Women's Health and Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Chesapeake Urology
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Beaumont Health System
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Metro Urology
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Adult & Pediatric Urology and Urogynecology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Urogynecology & Pelvic Reconstructive Surgery - Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Princeton Medical Center
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
8540
Country
United States
Facility Name
Athena Women's Institute for Pelvic Health
City
Turnersville
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
The Center for Specialized Women's Health
City
Whippany
State/Province
New Jersey
ZIP/Postal Code
07981
Country
United States
Facility Name
North Shore Women's Health Clinic
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Premier Medical Group
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Seven Hills Woman's Health Center
City
Cincinnati,
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Christ Hospital
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
The Institute for Female Pelvic Medicine - St. Luke's Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Center for Women's Health of Lansdale
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
The Female Pelvic Health Center
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
Swan Urogynecology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Lone Star Urogynecology and Continence Center
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
Facility Name
Female Pelvic Medicine Institute of Virginia
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Urology of Virginia, PLLC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Athena Women's Health
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98027
Country
United States
Facility Name
University of Washington Pelvic Health Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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