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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)

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ClinicalTrials.gov Identifier: NCT03643081
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Mild Primary Hyperparathyroidism Device: Use of the camera "Fluobeam" Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : May 20, 2021
Estimated Study Completion Date : May 20, 2021


Arm Intervention/treatment
Experimental: use of camera "Fluobeam" Device: Use of the camera "Fluobeam"
Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.

No Intervention: Without use of the camera "Fluobeam"



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643081


Contacts
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Contact: Eric MIRALLIE, Professor +33 2 40 08 33 33 eric.mirallie@chu-nantes.fr

Locations
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France
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Eric MIRALLIE, Professor         
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Eric MIRALLIE, Pr CHU de Nantes

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03643081     History of Changes
Other Study ID Numbers: RC18-0260
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs