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ACTIVE NOT RECRUITING
NCT04963179
NA

PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.

Sponsor: Womed

View on ClinicalTrials.gov

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

Interventions

DEVICE

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