Thyroid SurgeryECA_SPAFLUONCT06011369
Study of Usefulness of Fluorescence in Thiroid Surgery
A study testing Fluorescence in thyroid surgery in people with Thyroid Surgery, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- Fluorescence in thyroid surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total thyroidectomy with/without lymph node dissection
- Signature of informed consent
Who cannot join
- Patients under 18 years of age
- Hemithyroidectomy
- Reintervention of thyroid surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Beatriz Febrero, MD
About this study
Official title: A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery
In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. This study aims to determine the advantages offered by fluorescence in thyroid surgery, taking into account various clinical variables.
For this, a randomized study is proposed in patients undergoing thyroid surgery with and without cervical fluorescence.
- Conditions
- Thyroid Surgery
- Being tested
- Fluorescence in thyroid surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence in thyroid surgeryProcedure or surgery
Fluorescence in thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence in thyroid surgery | Experimental | Patients undergoing thyroid surgery with cervical fluorescence. Receives: Procedure: Fluorescence in thyroid surgery |
| No Fluorescence in thyroid surgery | No intervention | patients undergoing thyroid surgery without cervical fluorescence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of surgery performed
total thyroidectomy/hemithyroidectomy; lymphadenectomy
Measured: Up to 12 months.
Number of parathyroid glands identified before the use of AF (Autofluorescence)
Gland count
Measured: Up to 12 months.
Number and location of parathyroid glands identified with the use of FA (Autofluorescence)
Gland count
Measured: Up to 12 months.
Quantification of each parathyroid gland with AF(Autofluorescence)
(two determinations in the same parathyroid gland, in total, eight determinations of the parathyroid glands parathyroid, and three determinations in the thyroid gland, the last being in a nodule if it'd exist
Measured: Up to 12 months.
Number of glands accidentally removed.
Gland count
Measured: Up to 12 months.
Number of autotransplanted glands.
Gland count
Measured: Up to 12 months.
Surgical time.
Hours of surgery
Measured: Up to 12 months.
Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
Number of surgeries using autofluorescence
Measured: Up to 12 months.
Concentration of PTH and calcium corrected by albumin and/or ionic
Value in analytics
Measured: 4, 24 Hours
Concentration of PTH and calcium corrected by albumin and/or ionic
Value in analytics
Measured: 6,12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PROSPECTIVE, CONTROLLED, RANDOMIZED
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz Febrero, MD, Principal investigator, HCUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011369
- Sponsor's protocol ID
- IMIB-SPAFLUO
- Acronym
- ECA_SPAFLUO
- Status last verified
- Sep 2023
- First submitted
- 1 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT06011369
- Acronym / sponsor ID
- ECA_SPAFLUO / IMIB-SPAFLUO
- Conditions
- Thyroid Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Aug 2023 (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.
In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. This study aims to determine the advantages offered by fluorescence in thyroid surgery, taking into account various clinical variables.
For this, a randomized study is proposed in patients undergoing thyroid surgery with and without cervical fluorescence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PROSPECTIVE, CONTROLLED, RANDOMIZED
| Arm | Type | Receives |
|---|---|---|
| Fluorescence in thyroid surgery | Experimental | Procedure: Fluorescence in thyroid surgeryPatients undergoing thyroid surgery with cervical fluorescence. |
| No Fluorescence in thyroid surgery | No intervention | –patients undergoing thyroid surgery without cervical fluorescence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Total thyroidectomy with/without lymph node dissection
- Signature of informed consent
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Hemithyroidectomy
- Reintervention of thyroid surgery
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 |
|---|---|---|
| Fluorescence in thyroid surgeryFluorescence in thyroid surgery | Procedure or surgery | Fluorescence in thyroid surgery |
Primary outcome
Type of surgery performed
Time frame: Up to 12 months.
total thyroidectomy/hemithyroidectomy; lymphadenectomy
Number of parathyroid glands identified before the use of AF (Autofluorescence)
Time frame: Up to 12 months.
Gland count
Number and location of parathyroid glands identified with the use of FA (Autofluorescence)
Time frame: Up to 12 months.
Gland count
Quantification of each parathyroid gland with AF(Autofluorescence)
Time frame: Up to 12 months.
(two determinations in the same parathyroid gland, in total, eight determinations of the parathyroid glands parathyroid, and three determinations in the thyroid gland, the last being in a nodule if it'd exist
Number of glands accidentally removed.
Time frame: Up to 12 months.
Gland count
Number of autotransplanted glands.
Time frame: Up to 12 months.
Gland count
Surgical time.
Time frame: Up to 12 months.
Hours of surgery
Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
Time frame: Up to 12 months.
Number of surgeries using autofluorescence
Concentration of PTH and calcium corrected by albumin and/or ionic
Time frame: 4, 24 Hours
Value in analytics
Concentration of PTH and calcium corrected by albumin and/or ionic
Time frame: 6,12 Months
Value in analytics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- 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.
Beatriz Febrero, MD principal investigator
HCUVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence in thyroid surgery in people with Thyroid Surgery, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Sep 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Febrero, MD (968 36 95 00, beatriz.febrero@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of surgery performed (time frame: Up to 12 months.). The study lists 10 primary outcomes in all. 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 6 Sep 2023.