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)
Primary Purpose
Mild Primary Hyperparathyroidism
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of the camera "Fluobeam"
Sponsored by
About this trial
This is an interventional diagnostic trial for Mild Primary Hyperparathyroidism
Eligibility 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.
Sites / Locations
- CHU de NantesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
use of camera "Fluobeam"
Without use of the camera "Fluobeam"
Arm Description
Outcomes
Primary Outcome Measures
To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".
Secondary Outcome Measures
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.
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of number of visualized parathyroid glands.
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of post-surgery laryngeal paralysis.
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)
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.
Full Information
NCT ID
NCT03643081
First Posted
August 21, 2018
Last Updated
December 14, 2020
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03643081
Brief 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
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Primary Hyperparathyroidism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
use of camera "Fluobeam"
Arm Type
Experimental
Arm Title
Without use of the camera "Fluobeam"
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Use of the camera "Fluobeam"
Intervention Description
Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery.
Description
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.
Time Frame
At 6 months post parathyroïdectomy
Title
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)
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric MIRALLIE, Professor
Phone
+33 2 40 08 33 33
Email
eric.mirallie@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric MIRALLIE, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric MIRALLIE, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Interest of the Medical Device Called "Fluobeam" in the Localization, Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism
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