Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules

NCT ID: NCT04277455

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2023-09-28

Brief 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. 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.

Conditions

Thyroid Nodule

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Patients will receive laser treatment for benign symptomatic nodules

Group Type: EXPERIMENTAL

Laser ablation of benign thyroid nodule

Intervention Type: DEVICE

Ablating symptomatic benign thyroid nodules using laser

Interventions

Laser ablation of benign thyroid nodule

Ablating symptomatic benign thyroid nodules using laser

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mercy Research

OTHER

Sponsor Role: collaborator

Johnson Thomas

OTHER

Sponsor Role: lead

Responsible Party

Johnson Thomas

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johnson Thomas, MD, FACE

Role: PRINCIPAL_INVESTIGATOR

Mercy Research

Locations

Mercy Clinic Endocrinology - Smith Glynn Callaway

Springfield, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26274342 (View on PubMed)

Papini 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.

Reference Type: BACKGROUND

PMID: 25050903 (View on PubMed)

Pacella 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.

Reference Type: BACKGROUND

PMID: 28605944 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-113

Identifier Type: -

Identifier Source: org_study_id