Clostridium Histolyticum Collagenase Injection for Urethral Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

May 22, 2020

Primary Completion Date

March 4, 2023

Study Completion Date

April 12, 2023

Conditions
Urethral Stricture
Interventions
DRUG

Clostridium Histolyticum Collagenase

0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring.

OTHER

Saline

0.08ml of injectable normal saline

Trial Locations (1)

33606

University of South Florida - South Tampa Campus, Tampa

All Listed Sponsors
lead

University of South Florida

OTHER

NCT02948842 - Clostridium Histolyticum Collagenase Injection for Urethral Disease | Biotech Hunter | Biotech Hunter