Feasibility of Ultra-sound Guided Radiofrequency Ablation NCT00381225

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Withdrawn

To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the management of head and neck neoplasia.

The study evaluates the feasibility of radio-frequency ablation in the management of head and neck neoplasia.

Recruitment information / eligibility
Status	Withdrawn
Enrollment	0
Est. completion date	March 18, 2008
Est. primary completion date	March 18, 2008
Accepts healthy volunteers	No
Gender	All
Age group	18 Years to 90 Years
Eligibility	Inclusion Criteria: - Patients with head and neck neoplasia. Exclusion Criteria: - When the patient does not meet the inclusion criteria. - When the patient has a contra-indication of surgery or anesthesia. - If the patient refuses involvement in the study.

Procedure:
• Ultra-sound guided radio-frequency ablation

Locations
Country	Name	City	State
United States	Johns Hopkins University School of Medicine, Department of Otolaryngology-Head and Neck Surgery	Baltimore	Maryland

Sponsors *(1)*
Lead Sponsor	Collaborator
Johns Hopkins University

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Technical success is defined as the ability to successfully enter the thyroid nodule via ultrasound guidance and apply the RFA. Assessed via surgeon self report	Length of the procedure, up to 1 hour