Head and Neck NeoplasiaNCT00381225
Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.
A study testing Ultra-sound guided radio-frequency ablation in people with Head and Neck Neoplasia, run by Johns Hopkins University at 1 site in United States.
Trial summary
To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the management of head and neck neoplasia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head and Neck Neoplasia
- What is being tested?
- Ultra-sound guided radio-frequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to 18 Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with head and neck neoplasia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine, Department of Otolaryngology-Head and Neck Surgery
Baltimore, Maryland, 21287
About this study
To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the management of head and neck neoplasia.
Read the detailed description
The study evaluates the feasibility of radio-frequency ablation in the management of head and neck neoplasia.
- Conditions
- Head and Neck Neoplasia
- Being tested
- Ultra-sound guided radio-frequency ablation
- Keywords
- Radio-frequency ablation; Head and Neck neoplasia.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-sound guided radio-frequency ablationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ultra-sound guided radio-frequency ablation | Experimental | Not described Receives: Procedure: Ultra-sound guided radio-frequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Length of the procedure, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startNov 2006
- Primary completion18 Mar 2008
- Study completion18 Mar 2008
Why it stopped: Administratively withdrawn by the IRB prior to IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kieran Murphy, M.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381225
- Sponsor's protocol ID
- NA_00002641
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2006
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.
- ClinicalTrials.gov ID
- NCT00381225
- Acronym / sponsor ID
- NA_00002641
- Conditions
- Head and Neck Neoplasia
- Keywords
- Radio-frequency ablation; Head and Neck neoplasia.
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administratively withdrawn by the IRB prior to IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- 18 Mar 2008 (actual)
- Study completion
- 18 Mar 2008 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultra-sound guided radio-frequency ablation | Experimental | Procedure: Ultra-sound guided radio-frequency ablation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with head and neck neoplasia.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-sound guided radio-frequency ablation | Procedure or surgery | Ultra-sound guided radio-frequency ablation |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kieran Murphy, M.D principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-sound guided radio-frequency ablation in people with Head and Neck Neoplasia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Length of the procedure, up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.