Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts — ATIM  

Upper Digestive Tract Cancer Clinical Trial

Official title: Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

Status Terminated

Clinical Trial Summary

Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

Clinical Trial Description

• Investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps

• Investigate the accuracy of inserting implants in the anteroposterior way, in the vertical way and in angulation for all the involved patients (meaning on irradiated native mandible or on microanastomosed fibula flaps)

• Investigate the delay of mucous healing

• Estimate the prosthetic function

• Evaluate the osteonecrosis rate after radiation with traumatic etiology due to implantation

• Estimate the implant rate due to minimally invasive flaps

• Estimate the implant rate due to pure trans mucosa way

• Estimate the post surgical therapeutic success after 1 year ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Upper Digestive Tract Cancer

• NCT number: NCT00925509
• Study type: Interventional
• Source: Centre Leon Berard
• Status: Terminated
• Phase: N/A
• Start date: September 2007
• Completion date: December 2011