Pelvic Organ ProlapsePhase 4Harmony 522NCT02123992

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

A Phase 4 study testing Elevate Apical and Posterior and Native Tissue Repair for pelvic organ prolapse in people with Pelvic Organ Prolapse, run by ASTORA Women's Health at 23 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse
What is being tested?: Elevate Apical and Posterior and Native Tissue Repair for pelvic organ prolapse
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 23 sitesUnited States
Study dates: Apr 2014to Apr 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 15Show fewer

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

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

The Institute for Female Pelvic Medicine - St. Luke's Hospital
Allentown, Pennsylvania, 18103
The Womens Centre
Denton, Texas, 76210
Women's Health Advantage
Fort Wayne, Indiana, 46825
University of Texas at Galveston
Galveston, Texas, 77555
North Shore Women's Health Clinic
Great Neck, New York, 11021
Athena Women's Health
Issaquah, Washington, 98027
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Delaware Valley Urology
Mount Laurel, New Jersey, 08054
Swan Urogynecology
Nashville, Tennessee, 37203
Yale School of Medicine
New Haven, Connecticut, 06520
The Clark Center for Urogynecology
Newport Beach, California, 92663
The Female Pelvic Health Center
Newtown, Pennsylvania, 18940
Female Pelvic Medicine Institute of Virginia
North Chesterfield, Virginia, 23235
Adult & Pediatric Urology and Urogynecology
Omaha, Nebraska, 68114
Premier Medical Group
Poughkeepsie, New York, 12601
Princeton Medical Center
Princeton, New Jersey, 08540
Lone Star Urogynecology and Continence Center
Round Rock, Texas, 78665
University of Washington Pelvic Health Center
Seattle, Washington, 98195
Urological Associates of Southern Arizona
Tucson, Arizona, 85941
National Center for Advanced Pelvic Surgery
Washington D.C., District of Columbia, 20010
The Center for Specialized Women's Health
Whippany, New Jersey, 07981
Metro Urology
Woodbury, Minnesota, 55125

Other trials in United States

About this study

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

Read the 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.

Conditions: Pelvic Organ Prolapse
Being tested: Elevate Apical and Posterior, Native Tissue Repair for pelvic organ prolapse
Medical subject headings: Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Elevate Apical and PosteriorDevice
Native Tissue Repair for pelvic organ prolapseProcedure or surgery

Study groups in NCT02123992
Study group	Role	What they receive
Elevate Apical and Posterior	Active comparator	The experimental arm of the study will include the implantation of the Elevate Posterior surgical mesh for the treatment of posterior vaginal prolapse Receives: Device: Elevate Apical and Posterior
Native Tissue Repair	Active comparator	The control arm of the study will include the treatment of posterior vaginal prolapse using standard surgical sutures Receives: Procedure: Native Tissue Repair for pelvic organ prolapse

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Apr 2019

First posted28 Apr 2014 (estimated)
Study startApr 2014
Primary completionApr 2019 (estimated)
Study completionApr 2019 (estimated)

Why it stopped: Astora business is closing

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02123992
Sponsor's protocol ID: PR1206
Acronym: Harmony 522
Status last verified: Sep 2016
First submitted: 24 Apr 2014
Last updated: 7 Sep 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Data will be shared at a later data by the American Urogynecology Society aggregated with other data extracted from a national registry database.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02123992
Acronym / sponsor ID: Harmony 522 / PR1206
Conditions: Pelvic Organ Prolapse
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Astora business is closing
Enrolment: 99 participants (actual)
Lead sponsor: ASTORA Women's HealthIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Apr 2019 (estimated)
Study completion: Apr 2019 (estimated)
First posted: 28 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Elevate Apical and Posterior	Active comparator	Device: Elevate Apical and PosteriorThe experimental arm of the study will include the implantation of the Elevate Posterior surgical mesh for the treatment of posterior vaginal prolapse
Native Tissue Repair	Active comparator	Procedure: Native Tissue Repair for pelvic organ prolapseThe control arm of the study will include the treatment of posterior vaginal prolapse using standard surgical sutures

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Elevate Apical and Posterior	Device	Elevate Apical and Posterior
Native Tissue Repair for pelvic organ prolapse	Procedure or surgery	Native Tissue Repair

Primary outcome

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

3 secondary outcomes

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

Results and safety

The study was stopped early (reason given: Astora business is closing). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
Individual participant dataSharing planned: Yes. Data will be shared at a later data by the American Urogynecology Society aggregated with other data extracted from a national registry database.

Related trials for Pelvic Organ Prolapse

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric R Sokol, MD principal investigator

Stanford University

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Astora business is closing). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02123992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.