Trial record 14 of 73 for:    harmony

Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse (Harmony 522)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by American Medical Systems
Information provided by (Responsible Party):
American Medical Systems Identifier:
First received: April 24, 2014
Last updated: February 26, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Posterior Pelvic Organ Prolapse
Posterior and Apical Pelvic Organ Prolapse
Device: Elevate Apical and Posterior
Procedure: Native Tissue Repair for pelvic organ prolapse
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Rate of device or procedure related serious adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Rate of repeat surgery/revision for prolapse arising from the same site/target compartment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Changes in Quality of Life measured through the following questionaires: PFDI- 20,PFIQ-7, PISQ-12 [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Subjects experiencing adverse events related to device or procedure [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Subjects experiencing vaginal bulge [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Subjects experiencing prolapse at or beyond the hymenal ring [Time Frame: 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 494
Study Start Date: April 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Elevate Apical and Posterior Device: Elevate Apical and Posterior
Active Comparator: Native Tissue Repair Procedure: Native Tissue Repair for pelvic organ prolapse


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02123992

Contact: Dave Munneke, MS

United States, Arizona
Urological Associates of Southern Arizona Recruiting
Tucson, Arizona, United States, 85941
Contact: Crystal Robles    520-351-5582   
Principal Investigator: Mitzi Barmatz, MD         
United States, California
The Clark Center for Urogynecology Recruiting
Newport Beach, California, United States, 92663
Contact: Lauren Kiscaden    949-650-4730   
Principal Investigator: Matthew Clark, MD         
Sub-Investigator: Varuna Raizada, MD         
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Luisa Coraluzzi    203-785-6927   
Principal Investigator: Richard Bercik, M.D.         
United States, District of Columbia
National Center for Advanced Pelvic Surgery Recruiting
Washington, District of Columbia, United States, 20010
Contact: Joanna Peterson    202-877-0526   
Principal Investigator: Andrew Sokol, MD         
Sub-Investigator: Robert Gutman, MD         
Sub-Investigator: Amy Park, MD         
Sub-Investigator: Cheryl Iglesia, MD         
United States, Indiana
Women's Health Advantage Recruiting
Fort Wayne, Indiana, United States, 46825
Contact: Teresa Brousseau    260-432-4400   
Principal Investigator: Scott Boyd, MD         
Sub-Investigator: Craig Hanson, MD         
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Karen McWhirter    702-693-6870   
Contact: Jackelyne Amador    702-693-6870   
Principal Investigator: Geoffrey Hsieh, MD         
United States, New Jersey
Princeton Medical Center Recruiting
Princeton, New Jersey, United States, 8540
Contact: Alison Cooke    609-924-2230   
Principal Investigator: Heather van Raalte, MD         
Athena Women's Institute for Pelvic Health Recruiting
Turnersville,, New Jersey, United States, 08012
Contact: Kristin Vetterely    856-374-1377   
Principal Investigator: Elizabeth Babin, MD         
Sub-Investigator: Timothy McKinney, MD         
The Center for Specialized Women's Health Recruiting
Whippany, New Jersey, United States, 07981
Contact: Erin Dicks    973-625-6377   
Principal Investigator: Michael Ingber, MD         
Sub-Investigator: Paul Littman, MD         
United States, New York
North Shore Women's Health Clinic Recruiting
Great Neck, New York, United States, 11021
Contact: Christina Tso    516-622-5114   
Principal Investigator: Harvey Winkler, M.D.         
Sub-Investigator: Dara Shalom, MD         
Premier Medical Group Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Kimberly Secord    845-437-5002   
Principal Investigator: Daniel Katz, MD         
United States, Pennsylvania
The Institute for Female Pelvic Medicine - St. Luke's Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Marcie Taff    610-390-8204   
Principal Investigator: Vincent Lucente, MD         
Sub-Investigator: Miles Murphy, MD         
The Female Pelvic Health Center Recruiting
Newtown, Pennsylvania, United States, 18940
Contact: Megan Blatz    267-614-6751   
Principal Investigator: Stephanie Molden, MD         
United States, Tennessee
Swan Urogynecology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Tabitha Mondrage    615-515-9180   
Principal Investigator: Michael Swan, M.D.         
United States, Texas
The Womens Centre Recruiting
Denton, Texas, United States, 76210
Contact: Melinda Renfroe    940-387-6248   
Principal Investigator: Suhas Mantri, MD         
University of Texas at Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Carrie Derkowski    281-433-0047    caderkow@UTMB.EDU   
Principal Investigator: Tristi Muir, M.D.         
Sub-Investigator: Catalin Jurnalov, M.D.         
Dr. M. Mitchell Silver FACOG PA (D.O.) Recruiting
Nacogdoches, Texas, United States, 75965
Contact: Kandyce Silver    936-560-2782   
Principal Investigator: M. Mitchell Silver, MD         
Lone Star Urogynecology and Continence Center Recruiting
Round Rock, Texas, United States, 78665
Contact: Audrey Baum    512-716-0861   
Principal Investigator: Tomas Antonini, MD         
United States, Washington
University of Washington Pelvic Health Center Recruiting
Seattle, Washington, United States, 98195
Contact: Chloe Kinsey    206-529-7214   
Principal Investigator: Suzette Sutherland, MD         
Sub-Investigator: Jane Miller, MD         
Sponsors and Collaborators
American Medical Systems
Principal Investigator: Eric R Sokol, MD Stanford University
  More Information

No publications provided

Responsible Party: American Medical Systems Identifier: NCT02123992     History of Changes
Other Study ID Numbers: PR1206
Study First Received: April 24, 2014
Last Updated: February 26, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical processed this record on April 23, 2015