Pelvic Organ ProlapsePhase 4EmbraceNCT02121977
Study of the Elevate Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
A Phase 4 study testing Elevate Anterior and Apical and Native Tissue Repair for pelvic organ prolapse in people with Pelvic Organ Prolapse, run by ASTORA Women's Health at 31 sites in United States.
Trial 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. 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 Anterior and Apical 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
- 285 participants
- Where
- 31 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 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
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 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
31 sites in 1 country.
31 sites in 1 country
United States31 sites
The Institute for Female Pelvic Medicine - St. Luke's Hospital
Allentown, Pennsylvania, 18103
Weinberg Center for Women's Health and Medicine
Baltimore, Maryland, 21202
Cedars-Sinai Medical Group
Beverly Hills, California, 21202
Seven Hills Woman's Health Center
Cincinnati, Ohio, 45242
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
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Urogynecology & Pelvic Reconstructive Surgery - Atlantic Health System
Morristown, New Jersey, 07960
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
Chesapeake Urology
Owings Mills, Maryland, 21117
Premier Medical Group
Poughkeepsie, New York, 12601
Princeton Medical Center
Princeton, New Jersey, 8540
Lone Star Urogynecology and Continence Center
Round Rock, Texas, 78665
Beaumont Health System
Royal Oak, Michigan, 48073
University of Washington Pelvic Health Center
Seattle, Washington, 98195
Urological Associates of Southern Arizona
Tucson, Arizona, 85941
Athena Women's Institute for Pelvic Health
Turnersville, New Jersey, 08012
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
National Center for Advanced Pelvic Surgery
Washington D.C., District of Columbia, 20010
The Christ Hospital
West Chester, Ohio, 45069
The Center for Specialized Women's Health
Whippany, New Jersey, 07981
Metro Urology
Woodbury, Minnesota, 55125
About this study
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
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Elevate Anterior and Apical, 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 Anterior and ApicalDevice
Native Tissue Repair for pelvic organ prolapseProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Elevate Anterior and Apical | Active comparator | Prolapse repair with mesh Receives: Device: Elevate Anterior and Apical |
| Native Tissue Repair | Active comparator | Prolapse repair with 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.
- First posted24 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
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASTORA Women's Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric R Sokol, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121977
- Sponsor's protocol ID
- PR1205
- Acronym
- Embrace
- Status last verified
- Sep 2016
- First submitted
- 22 Apr 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
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® Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair
- ClinicalTrials.gov ID
- NCT02121977
- Acronym / sponsor ID
- Embrace / PR1205
- Conditions
- Pelvic Organ Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Astora business is closing
- Enrolment
- 285 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
- 24 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elevate Anterior and Apical | Active comparator | Device: Elevate Anterior and ApicalProlapse repair with mesh |
| Native Tissue Repair | Active comparator | Procedure: Native Tissue Repair for pelvic organ prolapseProlapse repair with sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
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 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 Anterior and Apical | Device | Elevate Anterior and Apical |
| 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
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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
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elevate Anterior and Apical and Native Tissue Repair for pelvic organ prolapse in people with Pelvic Organ Prolapse, run by ASTORA Women's Health at 31 sites in United States.
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 5 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 31 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?
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.