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

This study has been withdrawn prior to enrollment.
(Administratively withdrawn by the IRB prior to IRB approval)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00381225
First Posted: September 27, 2006
Last Update Posted: September 8, 2017
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.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the management of head and neck neoplasia.

Condition Intervention
Head and Neck Neoplasia Procedure: Ultra-sound guided radio-frequency ablation

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: November 2006
Study Completion Date: March 18, 2008
Primary Completion Date: March 18, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultra-sound guided radio-frequency ablation 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00381225     History of Changes
Other Study ID Numbers: NA_00002641
First Submitted: September 26, 2006
First Posted: September 27, 2006
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