AutofluorescenceNCT05044351
Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial
A study testing Fluobeam LX and Conventional surgery without NIRAF assistance in people with Autofluorescence and Thyroidectomy, run by Regional Hospital West Jutland at 1 site in Denmark.
Trial summary
Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autofluorescence, Thyroidectomy, Autotransplantation
- What is being tested?
- Fluobeam LX and Conventional surgery without NIRAF assistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2021to 16 Oct 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 thyroid lobectomy
- Age > 18
- Able to understand patient information
- Able to give informed consent
Who cannot join
- Completion lobectomy
- Need for accelerated surgery
- Age < 18
- Unable to understand patient information
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otorhinolaryngology, Regional Hospital West Jutland
Holstebro, 7500
About this study
Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed:
Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.
Read the detailed description
Patients referred for hemithyroidectomy will be randomized to either:
(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.
- Conditions
- Autofluorescence, Thyroidectomy, Autotransplantation
- Being tested
- Fluobeam LX, Conventional surgery without NIRAF assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluobeam LXDevice
See arm description
Conventional surgery without NIRAF assistanceOther
Patients undergoing conventional hemithyroidectomy without NIRAF-assistance
| Study group | Role | What they receive |
|---|---|---|
| (A): NIRAF-assisted surgery | Experimental | Patients undergoing NIRAF-assisted hemithyroidectomy Receives: Device: Fluobeam LX |
| (B): Conventional surgery | Active comparator | Patients undergoing conventional hemithyroidectomy without NIRAF-assistance Receives: Other: Conventional surgery without NIRAF assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parathyroid gland identification rate
Measured: Will be assessed at the time of surgery
Secondary outcomes (2)
Rate of inadvertent parathyroid excision
Measured: Will be assessed one month following surgery
Rate of autotransplantation
Measured: Will be assessed at the time of 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 completion16 Sep 2023
- Study completion16 Oct 2023
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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital West Jutland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Abood, Regional Hospital West Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044351
- Sponsor's protocol ID
- Autofluorescence2.0
- Status last verified
- Nov 2023
- First submitted
- 5 Sep 2021
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abood A, Rolighed L, Ovesen T, Madsen SH, Vestergaard P, Triponez F. Autofluorescence-guided hemithyroidectomy in a low-volume thyroid institution with no experience in parathyroid surgery: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae075. doi: 10.1093/bjs/znae075.
PubMed 38573333
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05044351
- Acronym / sponsor ID
- Autofluorescence2.0
- Conditions
- Autofluorescence, Thyroidectomy, Autotransplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 16 Sep 2023 (actual)
- Study completion
- 16 Oct 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.
Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed:
Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.
Detailed description
Patients referred for hemithyroidectomy will be randomized to either:
(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| (A): NIRAF-assisted surgery | Experimental | Device: Fluobeam LXPatients undergoing NIRAF-assisted hemithyroidectomy |
| (B): Conventional surgery | Active comparator | Other: Conventional surgery without NIRAF assistancePatients undergoing conventional hemithyroidectomy without NIRAF-assistance |
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 thyroid lobectomy
- Age > 18
- Able to understand patient information
- Able to give informed consent
Key exclusion criteria (5 listed)
- Completion lobectomy
- Need for accelerated surgery
- Age < 18
- Unable to understand patient information
- Unable to give informed consent
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 LXSee arm description | Device | (A): NIRAF-assisted surgery |
| Conventional surgery without NIRAF assistancePatients undergoing conventional hemithyroidectomy without NIRAF-assistance | Other | (B): Conventional surgery |
Primary outcome
Parathyroid gland identification rate
Time frame: Will be assessed at the time of surgery
2 secondary outcomes
Rate of inadvertent parathyroid excision
Time frame: Will be assessed one month following surgery
Rate of autotransplantation
Time frame: Will be assessed at the time of 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 9 Nov 2023.
- Derived from this study: PubMed 38573333Abood A, Rolighed L, Ovesen T, Madsen SH, Vestergaard P, Triponez F. Autofluorescence-guided hemithyroidectomy in a low-volume thyroid institution with no experience in parathyroid surgery: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae075. doi: 10.1093/bjs/znae075.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluobeam LX and Conventional surgery without NIRAF assistance in people with Autofluorescence and Thyroidectomy, run by Regional Hospital West Jutland at 1 site 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 5 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 9 Nov 2023. 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 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?
Parathyroid gland identification rate (time frame: Will be assessed at the time of surgery). 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 NCT05044351, 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 9 Nov 2023.