An interventional study of Restorelle Smartmesh in Uterine Prolapse, sponsored by Michigan Institution of Women's Health PC. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Michigan Institution of Women's Health PC · Not applicable, Interventional, and Treatment
Among 39 studies in Uterine Prolapse with a site in United States — 1 open to participants now, 6 under way, none of them phase 3. Uterine Prolapse · United States.
Among the 39 studies in Uterine Prolapse with a site in United States, this one is the 25th largest by planned enrollment of the 29 interventional ones that give a count, is one of 6 that started in 2016, is one of 20 with no phase, and was the 25th registered.
111 studies on the registry are indexed under Uterine Prolapse; 18 are open to participants now.
Browse Uterine Prolapse studies →1 of the 39 studies in Uterine Prolapse with a site in United States is open now. Recruiting first, the newest first:
University Hospitals Cleveland Medical Center · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 16 Uterine Prolapse studies recruiting now, 10 (63%) set no upper age limit and 5 (31%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years to 90 Years · female · no healthy volunteers.
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39 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 6 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 70 across 76 interventional studies indexed under Uterine Prolapse.
Median enrollment 68 across the 29 interventional studies, 81 across the 10 observational. Of the 29 that completed or were terminated, 13 (45%) have results posted.
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5 of 39 have an industry lead sponsor. The 10 most frequent:
Michigan Institution of Women's Health PC is the lead sponsor of 8 studies on the registry; none are open to participants now.
Michigan Institution of Women's Health PC has 1 study filed under Uterine Prolapse — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 39 studies in Uterine Prolapse with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.
Device: Restorelle Smartmesh
Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
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.
Time frame: Within first two years after surgical procedure
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Aug 2016, a primary completion of Aug 2020 and a completion of Aug 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Michigan Institution of Women's Health PC