At a glance
ClinicalIndex Comparison RecordN/ACompleted· 31 enrolled
Drug / intervention
Restorelle Direct Fix A&Pdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Restorelle Direct Fix A&P for Female Pelvic Organ Prolapse: A Prospective Post Market Study
In Brief
An observational study evaluating Restorelle Direct Fix A&P for Pelvic Organ Prolapse (POP). Completed, enrolled 31 participants across 6 sites.
Detailed Summary
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPelvic Organ Prolapse (POP)
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionSep 2013
TodayJul 2026
First PostedJun 22, 2011
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.0 years ago
Interventions
Restorelle Direct Fix A&Pdevice
Restorelle Direct Fix A\&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic organs into or out of the vaginal canal.