Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

CompletedOBSERVATIONAL
Enrollment

297

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

August 31, 2016

Conditions
Hypocalcemia
Interventions
DEVICE

Near infrared camera (NIR)

"Surgical field was examined with NIR, during a few minutes (\<5') with room lights switched off, to avoid parasite lights, then conventional open thyroidectomy was resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, were checked visually.~NIR consisted 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 norm IEC 60601-2-41). It was provided by the Fluobeam® camera, which was 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 1 device)."

All Listed Sponsors
collaborator

Assistance Publique Hopitaux De Marseille

OTHER

lead

Hôpital Européen Marseille

OTHER

NCT02889952 - Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery | Biotech Hunter | Biotech Hunter