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Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00381225
Recruitment Status : Withdrawn (Administratively withdrawn by the IRB prior to IRB approval)
First Posted : September 27, 2006
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease Intervention/treatment
Head and Neck Neoplasia Procedure: Ultra-sound guided radio-frequency ablation

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.
Study Start Date : November 2006
Primary Completion Date : March 18, 2008
Study Completion Date : March 18, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultra-sound guided radio-frequency ablation Procedure: Ultra-sound guided radio-frequency ablation



Primary Outcome Measures :
  1. Technical success [ Time Frame: Length of the procedure, up to 1 hour ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT00381225


Locations
United States, Maryland
Johns Hopkins University School of Medicine, Department of Otolaryngology-Head and Neck Surgery
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kieran Murphy, M.D Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00381225     History of Changes
Other Study ID Numbers: NA_00002641
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Radio-frequency ablation; Head and Neck neoplasia.

Additional relevant MeSH terms:
Neoplasms