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Clinical Trial Summary

This is a phase 1b, multicenter, non-randomized prospective study involving an innovation phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to evaluate the safety and feasibility of oral/oropharyngeal reconstruction with the external pudendal free flap in two groups of patients. A maximum of 40 patients (20 patients per group) will be included in this IDEAL-1/2A phase study. Stage IDEAL-1: Innovation phase. The main objective is to evaluate the feasibility in terms of limiting surgical complications of a STEPA flap reconstruction in two groups of patients (Cohort: Male, Female). Stage IDEAL-2A: Prospective development phase. The main objective is to describe the complication profile of the surgical procedure in these two patient populations. Each patient will be followed during 12 months after the end of complete treatment (surgery ± adjuvant treatment). A complementary study (observational study) of 250 patients will also be conducted to evaluate the acceptability of the technique (reconstruction by external pudendal flap) by the patients and to describe the factors associated with this acceptability.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05757817
Study type Interventional
Source Institut Claudius Regaud
Contact Agnès DUPRET-BORIES
Phone 05 31 15 53 08
Email dupret-bories.agnes@iuct-oncopole.fr
Status Recruiting
Phase N/A
Start date November 8, 2023
Completion date January 2027

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