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

Mild Primary Hyperparathyroidism Clinical Trial

— FLUO-PARA  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643081
• Other study ID #: RC18_0260
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: January 8, 2024

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult between 18 and 80 years old.

• Given signed written informed consent.

• Patient with moderated and sporadic primary hyperparathyroism (albumin-corrected serum calcium =2.85 mmol/l) requiring to be operated on.

• Patient affiliated to a social security system.

Exclusion Criteria:

• Underage and adults under guardianship.

• Pregnant or breast feeding women.

• Patients with history of cervical radiotherapy or cervicotomy.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Mild Primary Hyperparathyroidism

Intervention

Device:
• Use of the camera "Fluobeam"
Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".		At Day 1(parathyroidectomy)
Secondary	To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery.	To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery determined by normocalcemia (2,20 mmol/L < calcium < 2,60 mmol/L) at 6 months post surgery.	At 6 months post parathyroïdectomy
Secondary	To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of number of visualized parathyroid glands.		At Day 1(parathyroidectomy)
Secondary	To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of post-surgery laryngeal paralysis.		At 6 months post parathyroïdectomy
Secondary	To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of parathyroid morbidity (hypocalcemia with calcémia below 2 mmol/L)		At 6 months post parathyroïdectomy
Secondary	To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of cost-utility analysis according to the societal perspective and over a 6 months' time horizon of the surgery.		At 6 months post parathyroïdectomy