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)

January 22, 2024 updated by: Nantes University Hospital

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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"

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".
Time Frame: At Day 1(parathyroidectomy)
At Day 1(parathyroidectomy)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At 6 months post parathyroïdectomy
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)
At Day 1(parathyroidectomy)
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
At 6 months post parathyroïdectomy
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
At 6 months post parathyroïdectomy
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
At 6 months post parathyroïdectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric MIRALLIE, Pr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC18_0260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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