AutofluorescenceNCT05043584
Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions
A study testing Fluobeam LX, Fluoptics, Grenoble, France in people with Autofluorescence and Thyroidectomy, run by Regional Hospital West Jutland at 2 sites in Denmark.
Trial summary
Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autofluorescence, Thyroidectomy, Hypoparathyroidism
- What is being tested?
- Fluobeam LX, Fluoptics, Grenoble, France
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Sep 2021to 1 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for total thyroidectomy
- Age > 18
- Able to understand patient information
- Able to give informed consent
Who cannot join
- Previous thyroid surgery
- Need for accelerated surgery
- Insufficient biochemical profile
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Otorhinolaryngology, Hospital South West Jutland
Esbjerg, 6700
Department of Otorhinolaryngology, Regional Hospital West Jutland
Holstebro, 7500
About this study
Official title: Autofluorescence-guided Thyroid Surgery: Impact on Parathyroid Preservation and Hypoparathyroidism
Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.
Read the detailed description
Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX) at two low-volume ENT-departments with no experience in parathyroid surgery.
PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.
- Conditions
- Autofluorescence, Thyroidectomy, Hypoparathyroidism, Hypocalcemia
- Being tested
- Fluobeam LX, Fluoptics, Grenoble, France
- Medical subject headings
- Hypoparathyroidism, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluobeam LX, Fluoptics, Grenoble, FranceDevice
See arm description
| Study group | Role | What they receive |
|---|---|---|
| (A): NIRAF-assisted surgery | Experimental | Patients undergoing NIRAF-assisted total thyroidectomy Receives: Device: Fluobeam LX, Fluoptics, Grenoble, France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hypoparathyroidism
Measured: Will be assessed on postoperative day one, minimum two months and one year following surgery.
Secondary outcomes (3)
Parathyroid gland identification rate
Measured: Will be assessed at the time of surgery
Parathyroid autotransplantation rate
Measured: Will be assessed at the time of surgery
Rate of inadvertently excised parathyroid glands
Measured: Will be assessed 1 month following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start15 Sep 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutofluorescenceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital West Jutland
- Sponsor type
- University, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Principal investigator, Ali Abood, Regional Hospital West Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043584
- Sponsor's protocol ID
- Autofluorescence1.0
- Status last verified
- Dec 2023
- First submitted
- 5 Sep 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autofluorescence-guided Thyroid Surgery: Impact on Parathyroid Preservation and Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT05043584
- Acronym / sponsor ID
- Autofluorescence1.0
- Conditions
- Autofluorescence, Thyroidectomy, Hypoparathyroidism, Hypocalcemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 14 Sep 2021 (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.
Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.
Detailed description
Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX) at two low-volume ENT-departments with no experience in parathyroid surgery.
PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| (A): NIRAF-assisted surgery | Experimental | Device: Fluobeam LX, Fluoptics, Grenoble, FrancePatients undergoing NIRAF-assisted total thyroidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred for total thyroidectomy
- Age > 18
- Able to understand patient information
- Able to give informed consent
Key exclusion criteria (3 listed)
- Previous thyroid surgery
- Need for accelerated surgery
- Insufficient biochemical profile
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 |
|---|---|---|
| Fluobeam LX, Fluoptics, Grenoble, FranceSee arm description | Device | (A): NIRAF-assisted surgery |
Primary outcome
Rate of hypoparathyroidism
Time frame: Will be assessed on postoperative day one, minimum two months and one year following surgery.
3 secondary outcomes
Parathyroid gland identification rate
Time frame: Will be assessed at the time of surgery
Parathyroid autotransplantation rate
Time frame: Will be assessed at the time of surgery
Rate of inadvertently excised parathyroid glands
Time frame: Will be assessed 1 month following surgery
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 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluobeam LX, Fluoptics, Grenoble, France in people with Autofluorescence and Thyroidectomy, run by Regional Hospital West Jutland at 2 sites in Denmark.
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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Rate of hypoparathyroidism (time frame: Will be assessed on postoperative day one, minimum two months and one year following surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2024.