NCT04277455

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Johnson Thomas · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Laser ablation of benign thyroid nodule	Ablating symptomatic benign thyroid nodules using laser

Timeline

• Start date: 2020-10-26
• Primary completion: 2023-09-28
• Completion: 2023-09-28
• First posted: 2020-02-20
• Last updated: 2024-06-03
• Results posted: 2024-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study