Mild Primary HyperparathyroidismFLUO-PARANCT03643081
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 study testing Use of the camera "Fluobeam" in people with Mild Primary Hyperparathyroidism, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mild Primary Hyperparathyroidism
- What is being tested?
- Use of the camera "Fluobeam"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2018to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Underage and adults under guardianship.
- Pregnant or breast feeding women.
- Patients with history of cervical radiotherapy or cervicotomy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Mild Primary Hyperparathyroidism
- Being tested
- Use of the camera "Fluobeam"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the camera "Fluobeam"Device
Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.
| Study group | Role | What they receive |
|---|---|---|
| use of camera "Fluobeam" | Experimental | Not described Receives: Device: Use of the camera "Fluobeam" |
| Without use of the camera "Fluobeam" | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".
Measured: At Day 1(parathyroidectomy)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: At 6 months post parathyroïdectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start20 Dec 2018
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric MIRALLIE, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643081
- Sponsor's protocol ID
- RC18_0260
- Acronym
- FLUO-PARA
- Status last verified
- Jan 2024
- First submitted
- 21 Aug 2018
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frey S, Bannani S, Caillard C, Le Bras M, Drui D, Ansquer C, Guillot P, Le Thuaut A, Mirallie E. Parathyroid near-infrared autofluorescence use for parathyroidectomy in mild primary hyperparathyroidism: Results from a randomized monocentric trial. Surgery. 2025 Jan;177:108878. doi: 10.1016/j.surg.2024.05.062. Epub 2024 Oct 22.
PubMed 39443204
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03643081
- Acronym / sponsor ID
- FLUO-PARA / RC18_0260
- Conditions
- Mild Primary Hyperparathyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| use of camera "Fluobeam" | Experimental | Device: Use of the camera "Fluobeam" |
| Without use of the camera "Fluobeam" | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Underage and adults under guardianship.
- Pregnant or breast feeding women.
- Patients with history of cervical radiotherapy or cervicotomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the camera "Fluobeam"Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy. | Device | use of camera "Fluobeam" |
Primary outcome
To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".
Time frame: At Day 1(parathyroidectomy)
5 secondary outcomes
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 surgery with or without the utilization of the "Fluobeam" in term of number of visualized parathyroid glands.
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 39443204Frey S, Bannani S, Caillard C, Le Bras M, Drui D, Ansquer C, Guillot P, Le Thuaut A, Mirallie E. Parathyroid near-infrared autofluorescence use for parathyroidectomy in mild primary hyperparathyroidism: Results from a randomized monocentric trial. Surgery. 2025 Jan;177:108878. doi: 10.1016/j.surg.2024.05.062. Epub 2024 Oct 22.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric MIRALLIE, Pr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the camera "Fluobeam" in people with Mild Primary Hyperparathyroidism, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam". (time frame: At Day 1(parathyroidectomy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03643081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.