Thyroid NoduleNCT04277455
Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
A study testing Laser ablation of benign thyroid nodule in people with Thyroid Nodule, run by Johnson Thomas at 1 site in United States.
Trial summary
This is a prospective trial to evaluate the effects of laser ablation on symptomatic benign thyroid nodules. The study is designed to assess the clinical efficacy, safety, tolerability and impact on symptoms of single ultrasound guided laser ablation treatment of symptomatic benign thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Laser ablation of benign thyroid nodule
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 28 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, Age ≥18 years
- Thyroid Stimulating Hormone (TSH) within normal limits
- Presence of thyroid nodule >29 mm and ≤60 mm in the longest dimension on ultrasound imaging
- Symptoms from thyroid nodule - tightness or pressure in neck, neck tenderness, neck pain, difficulty swallowing, voice changes, shortness of breath or cosmetic disfigurement
- Solid thyroid nodule with less than 20% cystic component
- Cytological benign nodule proven by previous biopsy within 2 years
Show all 9Show fewer
- Ability to place the laser tip inside the nodule and to keep vital structures (i.e. trachea and esophagus) outside the zone of injury. To achieve this safe zone, we will leave a minimum of 17 mm distance between the fiber tip anterior to the vital structures and 10 mm from the fiber tip in all other dimensions.
- Not on anticoagulants or anticoagulants stopped for appropriate amount of time based on the pharmacology of the drug
- Ability to understand and willingness to provide informed consent
Who cannot join
- Pregnancy
- Diagnosis of Hyperthyroidism
- Malignant thyroid nodule
- Egg shell or coarse calcification in the thyroid nodule
- Patient on anticoagulation which cannot be stopped due to medical reasons
- Coagulopathy
Show all 18Show fewer
- Thyroid nodules in contact with trachea, esophagus or major blood vessels
- Prior neck surgery
- Prior radiation to head and neck
- Previous radioactive iodine treatment
- Current iodine supplementation
- Current anti-thyroid medication
- Biotin supplementation within 2 days prior to enrollment
- Allergy to Ethyl chloride spray or lidocaine
- Physical and psychological conditions that prevent safe administration of the procedure as determined by the investigator
- Adults not able to consent
- Prisoners
- Individuals who cannot read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercy Clinic Endocrinology - Smith Glynn Callaway
Springfield, Missouri, 65807
About this study
This is a prospective trial to evaluate the effects of laser ablation on symptomatic benign thyroid nodules. The study is designed to assess the clinical efficacy, safety, tolerability and impact on symptoms of single ultrasound guided laser ablation treatment of symptomatic benign thyroid nodules. Approximately 20 subjects will undergo laser ablation of symptomatic benign nodules.
Read the detailed description
- Laser ablation will be carried out in a single session under sterile conditions and ultrasound guidance with the support of Echolaser Smart Interface.
- Local anesthesia will be offered.
- The treatment plan will be assisted using the Echolaser Smart Interface.
- Depending on the shape and volume of the nodule to be treated, the investigator will determine whether one or two needles positioned parallel to each other along the longitudinal axis of the nodule will need to be used for treatment.
- Under ultrasound guidance, the investigator will introduce up to two 21-gauge introducer needles through the Guide kit into the target thyroid lesion percutaneously.
- Once the correct positioning of the needles has been verified under ultrasound imaging, an optical fiber is introduced into each needle with its tip protruding 5 mm out of the needle and in direct contact with the tissue to be ablated.
- Laser beam emission through the flat-tipped optical fiber produces a lesion (coagulation volume) within the nodule of an ellipsoidal shape, one third of which is positioned behind the tip of the fiber, and two-thirds in front.
- Each application session will last between 400 and 600 seconds under a laser source power output of 3W. An application is defined as the time between turning on and turning off the laser source.
- Up to 3 applications may be carried out during the same treatment session by pulling back along the needle and fiber axis by 0.5-1.0-1.5 cm to allow for treatment of tissue area not treated with previous application.
- Following completion of the laser ablation, the fibers will be removed followed by extraction of the needle(s). Hemostasis will be achieved at the site of needle insertion by applying pressure to the site.
- External bleeding will be assessed by visual inspection following extraction of the needle.
- Internal bleeding and potential nodule rupture will be assessed by ultrasound of the thyroid/neck with doppler flow assessment by the investigator following needle extraction using GE Logiq P6 ultrasound.The site will be covered with a sterile dressing/bandage.
- Conditions
- Thyroid Nodule
- Being tested
- Laser ablation of benign thyroid nodule
- Keywords
- Benign thyroid nodule
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ablation of benign thyroid noduleDevice
Ablating symptomatic benign thyroid nodules using laser
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients will receive laser treatment for benign symptomatic nodules Receives: Device: Laser ablation of benign thyroid nodule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation
Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment.
Measured: 12 months
Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation
Number of patients who develops hypo or hyperthyroidism 3,6 and 12 months after laser treatment.
Measured: 12 months
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation
Number of patients who had changes in blood flow inside the thyroid nodule as evidenced by change in Doppler grade.
Measured: 12 months
Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation
Number of patients who develops new thyroid antibodies 3,6, and 12 months after laser ablation
Measured: 12 months
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
Patients perceived cosmetic appearance will be measured using a numerical scale at baseline, immediately after procedure and then at 3, 6 and 12 months after procedure using following question. On a scale from 0 to 10, how much does your thyroid nodule affect your appearance? 0 being the best outcome and 10 being the worst outcome.
Measured: 3 months, 6 months, and 12 months after procedure
Secondary outcomes (6)
Reported Pain Score on the Numerical Scale Immediately Post Procedure.
Change in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible.
Measured: Immediately post-procedure
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Participants will be asked to answer the following questionnaire after the procedure.
How likely is it that you would have the laser ablation procedure again? 1 = Very Likely 2 = Somewhat Likely 3 = Not Likely
Measured: Post-procedure on the day of procedure
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Treatment related adverse events will be captured using CTCAE v4,0 format
Measured: 1 year
Reported Pain Score on the Numerical Scale 3 Months Post Procedure.
Change in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible.
Measured: 3 months
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Participants will be asked to answer the following questionnaire after the procedure.
How satisfied were you with the length of the laser ablation procedure? 1= Satisfied 2 = Neither 3 = Dissatisfied
Measured: Post-procedure on day of procedure
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Participants will be asked to answer the following questionnaire after the procedure.
How much discomfort did you have with the laser ablation procedure? 1= Less than I thought 2 = About what I thought 3 = More than I thought
Measured: Post-procedure on day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start26 Oct 2020
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson Thomas
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy Research
- Responsible party
- Sponsor-investigator, Johnson Thomas, Mercy Research
- Investigators
- Johnson Thomas, MD, FACE, Principal investigator, Mercy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277455
- Sponsor's protocol ID
- 18-113
- Status last verified
- May 2024
- First submitted
- 11 Feb 2020
- Last updated
- 3 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared
Publications
Pacella CM, Mauri G, Achille G, Barbaro D, Bizzarri G, De Feo P, Di Stasio E, Esposito R, Gambelunghe G, Misischi I, Raggiunti B, Rago T, Patelli GL, D'Este S, Vitti P, Papini E. Outcomes and Risk Factors for Complications of Laser Ablation for Thyroid Nodules: A Multicenter Study on 1531 Patients. J Clin Endocrinol Metab. 2015 Oct;100(10):3903-10. doi: 10.1210/jc.2015-1964. Epub 2015 Aug 14.
PubMed 26274342Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. Long-term efficacy of ultrasound-guided laser ablation for benign solid thyroid nodules. Results of a three-year multicenter prospective randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3653-9. doi: 10.1210/jc.2014-1826. Epub 2014 Jul 22.
PubMed 25050903Pacella CM, Mauri G, Cesareo R, Paqualini V, Cianni R, De Feo P, Gambelunghe G, Raggiunti B, Tina D, Deandrea M, Limone PP, Mormile A, Giusti M, Oddo S, Achille G, Di Stasio E, Misischi I, Papini E. A comparison of laser with radiofrequency ablation for the treatment of benign thyroid nodules: a propensity score matching analysis. Int J Hyperthermia. 2017 Dec;33(8):911-919. doi: 10.1080/02656736.2017.1332395. Epub 2017 Jun 12.
PubMed 28605944
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT04277455
- Acronym / sponsor ID
- 18-113
- Conditions
- Thyroid Nodule
- Keywords
- Benign thyroid nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johnson ThomasUniversity, hospital or other
- Collaborators
- Mercy Research
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 3 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective trial to evaluate the effects of laser ablation on symptomatic benign thyroid nodules. The study is designed to assess the clinical efficacy, safety, tolerability and impact on symptoms of single ultrasound guided laser ablation treatment of symptomatic benign thyroid nodules. Approximately 20 subjects will undergo laser ablation of symptomatic benign nodules.
Detailed description
- Laser ablation will be carried out in a single session under sterile conditions and ultrasound guidance with the support of Echolaser Smart Interface.
- Local anesthesia will be offered.
- The treatment plan will be assisted using the Echolaser Smart Interface.
- Depending on the shape and volume of the nodule to be treated, the investigator will determine whether one or two needles positioned parallel to each other along the longitudinal axis of the nodule will need to be used for treatment.
- Under ultrasound guidance, the investigator will introduce up to two 21-gauge introducer needles through the Guide kit into the target thyroid lesion percutaneously.
- Once the correct positioning of the needles has been verified under ultrasound imaging, an optical fiber is introduced into each needle with its tip protruding 5 mm out of the needle and in direct contact with the tissue to be ablated.
- Laser beam emission through the flat-tipped optical fiber produces a lesion (coagulation volume) within the nodule of an ellipsoidal shape, one third of which is positioned behind the tip of the fiber, and two-thirds in front.
- Each application session will last between 400 and 600 seconds under a laser source power output of 3W. An application is defined as the time between turning on and turning off the laser source.
- Up to 3 applications may be carried out during the same treatment session by pulling back along the needle and fiber axis by 0.5-1.0-1.5 cm to allow for treatment of tissue area not treated with previous application.
- Following completion of the laser ablation, the fibers will be removed followed by extraction of the needle(s). Hemostasis will be achieved at the site of needle insertion by applying pressure to the site.
- External bleeding will be assessed by visual inspection following extraction of the needle.
- Internal bleeding and potential nodule rupture will be assessed by ultrasound of the thyroid/neck with doppler flow assessment by the investigator following needle extraction using GE Logiq P6 ultrasound.The site will be covered with a sterile dressing/bandage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Laser ablation of benign thyroid nodulePatients will receive laser treatment for benign symptomatic nodules |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females, Age ≥18 years
- Thyroid Stimulating Hormone (TSH) within normal limits
- Presence of thyroid nodule >29 mm and ≤60 mm in the longest dimension on ultrasound imaging
- Symptoms from thyroid nodule - tightness or pressure in neck, neck tenderness, neck pain, difficulty swallowing, voice changes, shortness of breath or cosmetic disfigurement
- Solid thyroid nodule with less than 20% cystic component
Key exclusion criteria (18 listed)
- Pregnancy
- Diagnosis of Hyperthyroidism
- Malignant thyroid nodule
- Egg shell or coarse calcification in the thyroid nodule
- Patient on anticoagulation which cannot be stopped due to medical reasons
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 |
|---|---|---|
| Laser ablation of benign thyroid noduleAblating symptomatic benign thyroid nodules using laser | Device | Treatment arm |
Primary outcome
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation
Time frame: 12 months
Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment.
Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation
Time frame: 12 months
Number of patients who develops hypo or hyperthyroidism 3,6 and 12 months after laser treatment.
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation
Time frame: 12 months
Number of patients who had changes in blood flow inside the thyroid nodule as evidenced by change in Doppler grade.
Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation
Time frame: 12 months
Number of patients who develops new thyroid antibodies 3,6, and 12 months after laser ablation
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
Time frame: 3 months, 6 months, and 12 months after procedure
Patients perceived cosmetic appearance will be measured using a numerical scale at baseline, immediately after procedure and then at 3, 6 and 12 months after procedure using following question. On a scale from 0 to 10, how much does your thyroid nodule affect your appearance? 0 being the best outcome and 10 being the worst outcome.
6 secondary outcomes
Reported Pain Score on the Numerical Scale Immediately Post Procedure.
Time frame: Immediately post-procedure
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Time frame: Post-procedure on the day of procedure
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 1 year
Reported Pain Score on the Numerical Scale 3 Months Post Procedure.
Time frame: 3 months
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Time frame: Post-procedure on day of procedure
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Time frame: Post-procedure on day of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26274342Pacella CM, Mauri G, Achille G, Barbaro D, Bizzarri G, De Feo P, Di Stasio E, Esposito R, Gambelunghe G, Misischi I, Raggiunti B, Rago T, Patelli GL, D'Este S, Vitti P, Papini E. Outcomes and Risk Factors for Complications of Laser Ablation for Thyroid Nodules: A Multicenter Study on 1531 Patients. J Clin Endocrinol Metab. 2015 Oct;100(10):3903-10. doi: 10.1210/jc.2015-1964. Epub 2015 Aug 14.
- Background: PubMed 25050903Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. Long-term efficacy of ultrasound-guided laser ablation for benign solid thyroid nodules. Results of a three-year multicenter prospective randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3653-9. doi: 10.1210/jc.2014-1826. Epub 2014 Jul 22.
- Background: PubMed 28605944Pacella CM, Mauri G, Cesareo R, Paqualini V, Cianni R, De Feo P, Gambelunghe G, Raggiunti B, Tina D, Deandrea M, Limone PP, Mormile A, Giusti M, Oddo S, Achille G, Di Stasio E, Misischi I, Papini E. A comparison of laser with radiofrequency ablation for the treatment of benign thyroid nodules: a propensity score matching analysis. Int J Hyperthermia. 2017 Dec;33(8):911-919. doi: 10.1080/02656736.2017.1332395. Epub 2017 Jun 12.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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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.
Johnson Thomas, MD, FACE principal investigator
Mercy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser ablation of benign thyroid nodule in people with Thyroid Nodule, run by Johnson Thomas at 1 site in United States.
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 9 inclusion and 18 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 Jun 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation (time frame: 12 months). The study lists 5 primary outcomes in all. 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 NCT04277455, which also lists 3 linked publications.
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 Jun 2024.