Trial record 14 of 72 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 May 2015 by American Medical Systems
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT02123992
First received: April 24, 2014
Last updated: May 1, 2015
Last verified: May 2015
  Purpose

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

  Eligibility

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

  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 ClinicalTrials.gov identifier: NCT02123992

Contacts
Contact: Dave Munneke, MS dave.munneke@ammd.com

  Show 23 Study Locations
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: Eric R Sokol, MD Stanford University
  More Information

No publications provided

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT02123992     History of Changes
Other Study ID Numbers: PR1206
Study First Received: April 24, 2014
Last Updated: May 1, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2015