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PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
Sponsor: Womed
Summary
PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2021-11-29
Completion Date
2026-12
Last Updated
2025-03-27
Healthy Volunteers
No
Conditions
Interventions
Womed Leaf
Womed Leaf™ device is composed of a uterine anti-adhesion film pre-loaded inside a flexible inserter. Womed Leaf™ is inserted in the uterine cavity by the gynecologist surgeon as a film folded into a 5 mm diameter flexible inserter. Once released, the film will unfold and swell into the uterine cavity to keep uterus walls separated. It is degraded and discharged naturally through the cervix and vagina.
Locations (15)
Gent UZ
Ghent, Belgium
Guangdong Maternal and Child Health Hospital
Guangzhou, China
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, China
The Obstetrics & Gynecology Hospital Affiliated to Fudan University
Shanghai, China
Gynprenatal
Ostrava, Czechia
CHU Bicêtre
Le Kremlin-Bicêtre, France
CHU de Lille
Lille, France
Hopital La Conception
Marseille, France
CHU Lariboisière
Paris, France
Clinique Mutualiste La sagesse
Rennes, France
A.O.U Federico II
Naples, Italy
Aso Mauriziano Umberto I
Torino, Italy
Hospital Clinic Barcelonna
Barcelona, Spain
Ramon y Cajal Hospital
Madrid, Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland