RecruitingNot ApplicableNCT05463991

Bioengineered Collagen Implant for Urethral Stricture Repair

Bioengineered Collagen Scaffold Implant as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Distal Urethral Strictures. - A Pilot Stud


Sponsor

Regenosca SA

Enrollment

5 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria1

  • 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.

Exclusion Criteria11

  • Known bovine collagen allergy
  • Current urinary tract infection
  • Chronic renal failure
  • Diabeted
  • Neurological diseases
  • Chronic obstructive pulmonary diseases
  • Sleep disturbances
  • Depression
  • Former cancer treatment
  • Smokers
  • Recurrent stricture

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Interventions

DEVICEBioengineered collagen implant

Urethral stricture repair


Locations(1)

University of Malaya Medical Center

Kuala Lumpur, Malaysia

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NCT05463991


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