Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair

RecruitingOBSERVATIONAL
Enrollment

428

Participants

Timeline

Start Date

November 21, 2023

Primary Completion Date

December 31, 2031

Study Completion Date

December 31, 2031

Conditions
Genital Prolapse
Interventions
DEVICE

Restorelle Polypropylene Mesh

"The Coloplast Restorelle® Polypropylene Mesh is a Class III, implantable, permanent, non-absorbable, single use device indicated to restore female pelvic floor anatomy by providing anatomical support and suspension as a bridging material to support deficient fascia that resulted in descent of the female pelvic organs (pelvic organ prolapse).~Restorelle mesh is a synthetic, macroporous mesh constructed of medical grade knitted, monofilament polypropylene."

Trial Locations (10)

17019

RECRUITING

CH La Rochelle, La Rochelle

17108

NOT_YET_RECRUITING

CH de Saintonge, Saintes

33076

NOT_YET_RECRUITING

Centre Aliénor d'Aquitaine, Bordeaux

NOT_YET_RECRUITING

CHU Pellegrin, Bordeaux

33505

NOT_YET_RECRUITING

CH Général Robert Boulin, Libourne

35760

NOT_YET_RECRUITING

CH privé Saint Grégoire, Saint-Grégoire

43000

RECRUITING

Clinique Bon Secours, Le Puy-en-Velay

50300

NOT_YET_RECRUITING

Polyclinique de la Baie, Avranches

63500

NOT_YET_RECRUITING

CH Paul Ardier d'Issoire, Issoire

75014

NOT_YET_RECRUITING

Institut Mutualiste Montsouris, Paris

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

International Clinical Trials Association

OTHER

lead

Coloplast A/S

INDUSTRY