241
Participants
Start Date
September 30, 2016
Primary Completion Date
June 30, 2018
Study Completion Date
December 20, 2018
Near Infrared Camera (NIR)
Surgical field is examined with NIR, during a few minutes (\<5') with room lights switched off, to avoid parasite lights, then open thyroidectomy is resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, are checked visually. NIR consists of a 750 nm class 1 laser excitation, with a power \<20mW/cm2 (5 times less than the limit of 100mw/cm2, fixed by the international standard IEC 60601-2-41). It is provided by the Fluobeam® camera, which is inserted into a sterile cover and hold at a 15-20 cm distance from the patient. The system has an FDA 510(k) authorization for clinical use in parathyroid surgery and a European Community certification (Class 2A device).
Hopital Europeen, Marseille
Hôpital Saint Joseph Marseille, Marseille
Hopital La Pitie Salpetriere, Paris
Hôpital Européen Marseille
OTHER