Bioengineered Collagen Scaffold Implant as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Distal Urethral Strictures. - A Pilot Stud
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral strictures.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult males with urethral stricture less than 3 cm (anywhere from penile to bulbar urethra not including the membranous urethra) with existing lumen of at least 6 Fr suitable for augmentation urethroplasty. The stricture may be due to trauma or infection.
Locations
Other Locations
Malaysia
University of Malaya Medical Center
RECRUITING
Kuala Lumpur
Contact Information
Primary
Mattias Larsson
larsson@regenosca.com
+41765973705
Backup
Eva-Maria Balet
balet@regenosca.com
+41788687973
Time Frame
Start Date: 2022-08-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 5
Treatments
Experimental: Bioengineered collagen implant
Standard technique of doing a substitution urethroplasty with no modification to the surgical steps. Instead of an autologous oral bucal mucosa graft, the bioengineered collagen implant is sutured to the healty urethral area after incision of the urethra at the stricture location.
Related Therapeutic Areas
Sponsors
Leads: Regenosca SA