Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
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|ClinicalTrials.gov Identifier: NCT00615537|
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : April 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Nodule Thyroid Cancer Thyroid Neoplasms Nodular Goiter||Procedure: Laser Ablation of Thyroid Nodule||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Procedure: Laser Ablation of Thyroid Nodule
- PhoTex15 Diode Laser
- Visualase Cooled Laser Applictor System
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615537
|United States, Rhode Island|
|Rhode Island Hospital - Department of Diagnostic Imaging Research|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Damian Dupuy, MD||Rhode Island Hospital|