Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

NACompletedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

June 30, 2018

Study Completion Date

December 20, 2018

Conditions
Hypocalcemia
Interventions
DEVICE

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).

Trial Locations (3)

13003

Hopital Europeen, Marseille

13008

Hôpital Saint Joseph Marseille, Marseille

75013

Hopital La Pitie Salpetriere, Paris

All Listed Sponsors
lead

Hôpital Européen Marseille

OTHER

NCT02892253 - Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia | Biotech Hunter | Biotech Hunter