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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2024-01-08

Brief Summary

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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.

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Detailed Description

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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

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Mild Primary Hyperparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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use of camera "Fluobeam"

Group Type EXPERIMENTAL

Use of the camera "Fluobeam"

Intervention Type DEVICE

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

Without use of the camera "Fluobeam"

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Use of the camera "Fluobeam"

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

Intervention Type DEVICE

Eligibility Criteria

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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.