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

NAActive, not recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

November 29, 2021

Primary Completion Date

November 11, 2023

Study Completion Date

December 31, 2026

Conditions
Asherman SyndromeIntrauterine Adhesion
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."

Trial Locations (15)

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

9000

Gent UZ, Ghent

13005

Hopital La Conception, Marseille

28034

Ramon y Cajal Hospital, Madrid

35043

Clinique Mutualiste La sagesse, Rennes

59000

CHU de Lille, Lille

75010

CHU Lariboisière, Paris

80131

A.O.U Federico II, Napoli

94270

CHU Bicêtre, Le Kremlin-Bicêtre

Unknown

Guangdong Maternal and Child Health Hospital, Guangzhou

Women's Hospital School Of Medicine Zhejiang University, Hangzhou

The Obstetrics & Gynecology Hospital Affiliated to Fudan University, Shanghai

Gynprenatal, Ostrava

Aso Mauriziano Umberto I, Torino

Hospital Clinic Barcelonna, Barcelona

All Listed Sponsors
lead

Womed

INDUSTRY