NCT03643081

Evaluation of the Interest of the Medical Device Called "Fluobeam" in the Localization, Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism

Evaluation of the Interest of the Medical Device Called "Fluobeam" in the Localization, Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism. A Randomized Controled Prospective Open -Labeled Monocentric Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of our study is to evaluate the value of the camera called "Fluobeam" in the localization, visualization of the parathyroid glands for patients with mild primary hyperparathyroidism.

Detailed description

Recently, it has been shown that parathyroid glands presented auto fluorescence, visible in the near infra-red light. Parathyroid glands emit at 822 nanometers when they are stimulated by a laser of 785 nanometers. Fluoptics Company (Fluoptics SAS, Grenoble, France) will provide a camera called "Fluobeam", facilitating the visualization of the parathyroid glands. The fluorescence intensity of the parathyroid glands is much more elevated than that of the surrounding tissues. Preliminary work showed the interest of this technique. Benmiloud and collabortors have shown that the utilization of the "Fluobeam" enable to decrease the post total thyroidectomy hypocalcemia rate by a better visualization and preservation of the parathyroid glands. The aim of this study is to evaluate the value of "Fluobeam" in the localization, visualization of the parathyroid glands for patients with mild primary hyperparathyroidism.

Conditions

• Mild Primary Hyperparathyroidism

Interventions

Type	Name	Description
DEVICE	Use of the camera "Fluobeam"	Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.

Timeline

• Start date: 2018-12-20
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2018-08-22
• Last updated: 2024-01-23

Locations

1 site across 1 country: France