Feasibility of Ultra-sound Guided Radiofrequency Ablation... | NCT00381225

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

NCT00381225

Sponsor

Johns Hopkins University

Status

Withdrawn

Last Update Posted

Sep 8, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Head and Neck Neoplasia

Interventions

Ultra-sound guided radio-frequency ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Administratively withdrawn by the IRB prior to IRB approval

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Mar 18, 2008Actual

Completion Date

Mar 18, 2008Actual

First Submitted Date

Sep 26, 2006

First Submission Date that Met QC Criteria

Sep 26, 2006

First Posted Date

Sep 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2017

Last Update Posted Date

Sep 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultra-sound guided radio-frequency ablation	Experimental		Procedure: Ultra-sound guided radio-frequency ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultra-sound guided radio-frequency ablation	Procedure		Ultra-sound guided radio-frequency ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kieran Murphy, M.D	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University School of Medicine, Department of Otolaryngology-Head and Neck Surgery		Baltimore	Maryland	21287	United States