Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
Completed · Not applicable
Conditions studied: Thyroid Nodule, Thyroid Cancer, Thyroid Neoplasms, Nodular Goiter
In brief
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.
Key facts
- Study ID
- NCT00615537
- Run by
- BioTex, Inc.
- People needed
- 20
- Starts
- 2008-02-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2011-04-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically documented benign thyroid nodule, or cold thyroid nodule as documented by thyroid scan.
- Patient has been evaluated by endocrinology and endocrine surgery and has been deemed suitable candidate for procedure.
- The patient's nodule(s) size and number must be no larger than 5cm and a maximum of 3 nodules, respectively.
- All nodules must be greater than 1cm from the expected location of the recurrent laryngeal and vagus nerves determined under ultrasound.
- Required initial laboratory values: T3, T4. TSH, and Thyroglobulin (for treated metastatic lymph nodes)
- All patients must understand and sign a study-specific informed consent.
You may not qualify if…
- Thyroid mass in contact with trachea or esophagus.
- Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be ≥ 70,000/ul.)
- Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half-life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure.
Where it is running
- Rhode Island Hospital - Department of Diagnostic Imaging Research — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.