NCT00605826 - A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence | Biotech Hunter

Enrollment

206

Participants

Timeline

Start Date

September 7, 2006

Primary Completion Date

November 23, 2009

Study Completion Date

November 23, 2009

Conditions

Fecal Incontinence

Interventions

DEVICE

NASHA/Dx (Solesta) Gel

Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.

DEVICE

Sham Injection

Sham injection at the start of the blinded phase.

Trial Locations (13)

St. Luke's/Roosevelt Hospital, New York

University of South Florida College of Medicine, Tampa General Hospital, Tampa

Cleveland Clinic Foundation, Cleveland

Colon & Rectal Surgery Associates, Minneapolis

Colorectal Surgical Associates, Houston

Salt Lake Research/Center for Colon Rectal Disease, Salt Lake City

University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery, San Francisco

Lahey Clinic, Department of Colon & Rectal Surgery, Burlington

Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg, Erlangen

Kirurgmottagningen Universitetssjukhuset MAS, Malmo

Kirurgmottagningen, Danderyds Sjukhus, Stockholm

Kirurgkliniken, Uppsala Akademiska Sjukhus, Uppsala

Castle Hill Hospital, Department of Academic Surgery, Cottingham