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

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Mild Primary Hyperparathyroidism

Treatments

Device: Use of the camera "Fluobeam"

Study type

Interventional

Funder types

Other

Identifiers

NCT03643081
RC18_0260

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

132 participants in 2 patient groups

use of camera "Fluobeam"
Experimental group
Treatment:
Device: Use of the camera "Fluobeam"
Without use of the camera "Fluobeam"
No Intervention group

Trial contacts and locations

1

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Central trial contact

Eric MIRALLIE, Professor

Data sourced from clinicaltrials.gov

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