RecruitingNot ApplicableNCT04965025

Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage

MAGIC I TRIAL - Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage: a Randomized Controlled Pilot Study

Sponsor

University Hospital, Ghent

Enrollment

30 participants

Start Date

Nov 11, 2020

Study Type

INTERVENTIONAL

Conditions

Urethral Stricture Urethra Stenosis

Summary

The principal aim of this pilot study is to directly compare both approaches and analyze the failure rate after one year of follow-up. These data will serve as the basis to design a larger phase II or III trial in the future with failure rate as the primary end-point. Other study objectives are thoroughly described underneath.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Multi-stage urethroplasty with graft inlay in first stage and a procedure called Multi-stage urethroplasty with graft inlay in second stage for people with urethra stenosis and urethral stricture. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMulti-stage urethroplasty with graft inlay in first stage

Herein, the graft will be used in the first stage and the second stage will solely consist of retubularizing the urethra.

PROCEDUREMulti-stage urethroplasty with graft inlay in second stage

Herein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally.

Locations(1)

Ghent University Hospital

Ghent, Belgium

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NCT04965025

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