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Completed

NCT Number: 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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of the camera "Fluobeam"

Device

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

Primary outcomes

  1. To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".

    Time frame: At Day 1(parathyroidectomy)

Secondary outcomes

  1. To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery.

    Time frame: At 6 months post parathyroïdectomy

    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.

  2. To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of number of visualized parathyroid glands.

    Time frame: At Day 1(parathyroidectomy)

  3. To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of post-surgery laryngeal paralysis.

    Time frame: At 6 months post parathyroïdectomy

  4. 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)

    Time frame: At 6 months post parathyroïdectomy

  5. 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.

    Time frame: At 6 months post parathyroïdectomy

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: FLUO-PARA

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2018
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.