Restorelle® Mesh Versus Native Tissue Repair for Prolapse

CompletedOBSERVATIONAL
Enrollment

810

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

January 15, 2020

Study Completion Date

November 6, 2021

Conditions
Pelvic Organ Prolapse
Interventions
DEVICE

Restorelle Direct Fix A

DEVICE

Restorelle Direct Fix P

PROCEDURE

Native Tissue Repair Anterior

PROCEDURE

Native Tissue Repair Posterior

Trial Locations (49)

1081

Bergman Clinics, Amsterdam

1105

AMC Medical Center, Amsterdam

2065

Centre for Advanced Reproductive Endosurgery, St Leonards

3000

UZ Leuven, Leuven

4812

Mater Pelvic Health, Pimlico

10461

Montefiore Medical Research Center, The Bronx

12601

Premier Medical Group of Hudson Valley, PC, Poughkeepsie

17403

Wellspan Urogynecology and Pelvic Reconstructive Surgery, York

18103

The Institute for Female Pelvic Medicine and Reconstructive Surgery, Allentown

18940

The Female Pelvic Health Center, Newtown

19446

Center for Women's Health of Lansdale, Lansdale

19713

Center for Urogynecology and Pelvic Surgery, Christiana Care Health System, Newark

20010

MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery, Washington D.C.

21117

Andrew Shapiro, Owings Mills

23502

The Group for Women, Norfolk

24073

Carilion Clinic New River Valley, Christiansburg

27103

Novant Health Clinical Research, Winston-Salem

28210

Novant Health Urogynecology, Charlotte

28345

Women's Pelvic Health and Continence Center, Hamlet

30029

CHU Nimes, Nîmes

37203

Swan Urogynecology, Nashville

44109

MetroHealth Medical Center, Cleveland

44333

Akron Urogynecology Associates, Akron

45220

Good Samaritan Hospital, Cincinnati

49009

Beyer Research, Kalamazoo

49503

Female Pelvic Medicine & Urogynecology Institute of MI, Grand Rapids

57104

Sanford Research, Sioux Falls

59037

CHRU Lille, Lille

68114

Adult & Pediatric Urology, PC, Omaha

76034

Scott D. Lauer, DO, PA, Colleyville

78758

Central Texas Urogynecology and Continence Center, Austin

80218

SurgOne Pelvic Solutions Center, Denver

83404

Rosemark Women Care Specialists, Idaho Falls

91301

Sherry Thomas, M.D., Agoura Hills

94305

Stanford University, Stanford

98042

Integrity Medical Research, Mountlake Terrace

06520

Yale University School of Medicine, New Haven

01199

Baystate Health System, Springfield

08103

Cooper University Hospital, Camden

07960

Atlantic Health System, Morristown

K7L 2VT

Kingston General Hospital, Kingston

H1T 2M4

Hôpital Maisonneuve-Rosemount, Montreal

J1H 5N4

CHUS-CRC, Sherbrooke

3723 MB

Bergman Clinics, Bilthoven

4819 EV

Amphia Hospital, Breda

2035 RC

Spaarne Gasthuis, Haarlem

6229 HX

Maastricht UMC, Maastricht

3435 CM

St. Antonius Ziekenhuis, Nieuwegein

8025 AB

ISALA, Zwolle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY

NCT02162615 - Restorelle® Mesh Versus Native Tissue Repair for Prolapse | Biotech Hunter | Biotech Hunter