Clinical Trial: Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Brief Summary: This proposal is designed as a pilot study for the use of laser ablation for local control of symptomatic (e.g compressive) benign thyroid masses in 20 patients.

Detailed Summary:

Thyroid nodules are a very common clinical finding, with an estimated prevalence (based on palpation) ranging from 3% to 7% among the general population. With the widespread use of ultrasound (US), clinically unapparent thyroid nodule prevalence has dramatically increased with estimates at 20% to 76% in the general population. Moreover, 20% to 48% of patients with a single palpable thyroid nodule are found to have additional nodules when investigated by US.

Laser ablation therapy offer potential for the thermal destruction of soft tissue structures. The ability to deliver large doses of energy via small flexible fiberoptics makes laser therapy ideally suited for percutaneous treatment of unwanted tissue masses.

In this study we propose to treat symptomatic soft tissue thyroid masses in the head and neck region using a new FDA-cleard laser ablation system to safely and effectively debulk the tissue and therefore improve symptoms. Real time US monitoring will be performed of the ablation front to ensure complete treatment of the target lesion. All ablated regions will be followed by US with Doppler to document changes in size and vascularity. Local effects on thyroid function for thyroid mass treatment will be measured on follow-up.

Sponsor: BioTex, Inc.

Current Primary Outcome: The primary goal of this study is to determine the local response of laser ablation of the treated lesion and its effect on size and vascularity. The objective measures will be based on serial US with Doppler. [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To assess the effects of laser ablation on thyroid function testing. An estimate of time and cost associated with LITT procedure for treatment of soft tissue thyroid nodules. [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: BioTex, Inc.

Dates:
Date Received: February 3, 2008
Date Started: February 2008
Date Completion:
Last Updated: April 4, 2011
Last Verified: April 2011