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RECRUITING
NCT04965025
NA

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

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2020-11-11

Completion Date

2025-03-01

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

PROCEDURE

Multi-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.

PROCEDURE

Multi-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