Bioengineered Collagen Implant for Urethral Stricture Repair
NCT ID: NCT05463991
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2022-08-15
2025-12-31
Brief Summary
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Detailed Description
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Current available surgical techniques for urethral stricture repair require harvesting of grafts from autologous sites resulting in additional risks of complications at the tissue harvest site and additional pain to the patient.
The hypothesis of this study is that the developed bioengineered collagen implant can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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.
Bioengineered collagen implant
Urethral stricture repair
Interventions
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Bioengineered collagen implant
Urethral stricture repair
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Current urinary tract infection
* Chronic renal failure
* Diabeted
* Neurological diseases
* Chronic obstructive pulmonary diseases
* Sleep disturbances
* Depression
* Former cancer treatment
* Smokers
* Recurrent stricture
18 Years
MALE
No
Sponsors
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Regenosca SA
INDUSTRY
Responsible Party
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Principal Investigators
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Teng Aik Ong, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Malaya Medical Center
Locations
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University of Malaya Medical Center
Kuala Lumpur, , Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIH-BCI
Identifier Type: -
Identifier Source: org_study_id
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