CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Ringer lactate solution +1 moreother
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.

Search/NCT01388907
NCT01388907Phase 4Completed
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Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study

Medtronic - MITG·interventional·Posted Jul 7, 2011·Updated Nov 17, 2016

In Brief

A Phase 4 clinical trial evaluating Ringer lactate solution and Prevadh film for Uterine Fibroids and Fertility Disorders. Completed, enrolled 61 participants across 11 sites.

Detailed Summary

The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids, Fertility Disorders
CountriesFrance
CollaboratorsRegistrat-Mapi

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 7, 2011
Enrollment StartMay 1, 2006
Primary CompletionJun 1, 2008
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.0 years ago

Interventions

Ringer lactate solutionother

Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.

Prevadh filmdevice

Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.