Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT01035268
Brief Summary:
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.
It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.
follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\\or from a distance relapse.
During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.
Study:
NCT01035268
Study Brief:
Protocol Section:
NCT01035268