Back to resultsStudy of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse (Harmony 522)
Primary Purpose
Pelvic Organ Prolapse
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Elevate Apical and Posterior
Native Tissue Repair for pelvic organ prolapse
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
Subject is female
Subject is at least 18 years of age
Subject must have documented diagnosis of posterior or posterior 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 Bp ≥ 0; or Bp ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment posterior 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 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
- The Clark Center for Urogynecology
- Yale School of Medicine
- National Center for Advanced Pelvic Surgery
- Women's Health Advantage
- Metro Urology
- Adult & Pediatric Urology and Urogynecology
- Women's Cancer Center of Nevada
- Delaware Valley Urology
- Princeton Medical Center
- The Center for Specialized Women's Health
- North Shore Women's Health Clinic
- Premier Medical Group
- The Institute for Female Pelvic Medicine - St. Luke's Hospital
- Center for Women's Health of Lansdale
- The Female Pelvic Health Center
- Swan Urogynecology
- The Womens Centre
- University of Texas at Galveston
- Lone Star Urogynecology and Continence Center
- Female Pelvic Medicine Institute of Virginia
- 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 Apical and Posterior
Native Tissue Repair
Arm Description
The experimental arm of the study will include the implantation of the Elevate Posterior surgical mesh for the treatment of posterior vaginal prolapse
The control arm of the study will include the treatment of posterior vaginal prolapse using standard surgical 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
NCT ID
NCT02123992
First Posted
April 24, 2014
Last Updated
September 6, 2016
Sponsor
ASTORA Women's Health
1. Study Identification
Unique Protocol Identification Number
NCT02123992
Brief Title
Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
Acronym
Harmony 522
Official Title
A Prospective, Safety and Efficacy Cohort Study of Elevate® Apical and Posterior 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® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.
Detailed Description
The Harmony 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
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elevate Apical and Posterior
Arm Type
Active Comparator
Arm Description
The experimental arm of the study will include the implantation of the Elevate Posterior surgical mesh for the treatment of posterior vaginal prolapse
Arm Title
Native Tissue Repair
Arm Type
Active Comparator
Arm Description
The control arm of the study will include the treatment of posterior vaginal prolapse using standard surgical sutures
Intervention Type
Device
Intervention Name(s)
Elevate Apical and Posterior
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
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 posterior or posterior 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 Bp ≥ 0; or Bp ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment posterior 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 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
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
Women's Health Advantage
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
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
Delaware Valley Urology
City
Mt. Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Princeton Medical Center
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
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
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
The Womens Centre
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
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
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
IPD Sharing Plan Description
Data will be shared at a later data by the American Urogynecology Society aggregated with other data extracted from a national registry database.
Learn more about this trial
Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
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