- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02921451
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
August 12, 2019 updated by: Salil Khandwala, Michigan Institution of Women's Health PC
The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.
Study Overview
Detailed Description
This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management.
Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse.
However, this has often been found to be an unnecessary operation.
The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Dearborn, Michigan, United States, 48125
- Advanced Urogynecology of Michigan, P.C.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subject is female.
- Subject is at least 18 years of age.
- Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
- Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
- Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
- Subject is willing to provide written informed consent.
- Subject is willing and able to comply with follow-up regimen.
Exclusion Criteria:
- Subject is pregnant or intends to become pregnant in the future.
- Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
- Subject has undergone any previous repair for pelvic organ prolapse.
- Subject has undergone a hysterectomy.
- Subject lacks competency of the English language.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Restorelle Smartmesh
Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.
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Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
Time Frame: Within first two years after surgical procedure
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Success criteria will be defined through the examination of patient's Prolapse Quantification System Assessment (POPQ) score of C -1 or less and patient's report of bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 0 or 1 (i.e.
response of "not at all").
Failure to meet this criteria will be considered recurrence of uterine prolapse.
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Within first two years after surgical procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Salil Khandwala, Advanced Urogynecology of Michigan, P.C.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
September 23, 2016
First Submitted That Met QC Criteria
September 29, 2016
First Posted (Estimate)
October 3, 2016
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IISP 16-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uterine Prolapse
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TriHealth Inc.RecruitingProlapse; Female | Prolapse, Vaginal | Prolapse, UterineUnited States
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Lyra Medical Ltd.CompletedAnterior Vaginal Wall Prolapse | Vaginal Apex/Uterine ProlapseHungary, Israel
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Manchester University NHS Foundation TrustRecruitingProlapse; Female | Prolapse, VaginalUnited Kingdom
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National Taiwan University HospitalCompletedVault Prolapse, Vaginal
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Centre Hospitalier Universitaire de NīmesCompletedVaginal ProlapseFrance
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Azienda Ospedaliera Cardinale G. PanicoCompletedPelvic Organ Prolapse | Posterior Vaginal Wall ProlapseItaly
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Rambam Health Care CampusTerminated
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Rambam Health Care CampusUnknownVaginal Prolapse
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Larry SirlsCompleted
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University of South FloridaCompletedVaginal ProlapseUnited States
Clinical Trials on Restorelle Smartmesh
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Coloplast A/SInternational Clinical Trials AssociationRecruitingGenital ProlapseFrance
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Coloplast A/SCompletedPelvic Organ Prolapse (POP)United States
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Michigan Institution of Women's Health PCActive, not recruitingPelvic Organ ProlapseUnited States
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Coloplast A/SCompletedPelvic Organ ProlapseUnited States, France, Belgium, Netherlands, Australia, Canada
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The Cleveland ClinicCompletedVaginal Vault ProlapseUnited States