Thyroid NeoplasmsNCT00571077
Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study
An observational study of Thyroid Neoplasms and Thyroid Nodules, run by Hadassah Medical Organization at 2 sites in 2 countries.
Trial summary
Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan. Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be compared with final histopathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms, Thyroid Nodules
- What is being tested?
- Electrical Impedance Scanning (EIS) of the Thyroid gland
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2002to Dec 2007
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 with thyroid nodules scheduled for surgery.
Who may be able to join
- Patients over the age of 18 with thyroid nodules scheduled for surgery.
Who cannot join
- Pregnant patients
- PAtients with electrical powered devices (cardiac pacemakers)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Walter Reed Army MEdicla Center
Washington D.C., District of Columbia
About this study
Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan. Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be compared with final histopathology.
- Conditions
- Thyroid Neoplasms, Thyroid Nodules
- Being tested
- Electrical Impedance Scanning (EIS) of the Thyroid gland
- Keywords
- Thyroid neoplasms, thyroid nodules, electrical impedance scanning
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance Scanning (EIS) of the Thyroid glandDevice
Patients will be examined in the supine position. A cylinder electrode conveying 2.5V electrical current will be held by the patient. The patient will be scanned by a probe (similar to an ultrasound probe. The examination takes 5 minutes and there is no risk or discomfort.
| Study group | Role | What they receive |
|---|---|---|
| A | This is a a single arm study evaluating the efficacy and accuracy of EIS in detecting malignant thyroid nodules.
PAtients with thyroid nodules scheduled for surgery will undergo EIS examination. Receives: Device: Electrical Impedance Scanning (EIS) of the Thyroid gland |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of EIS
Measured: 5 years
Secondary outcomes (1)
NPV and PPV of EIS of the thyroid
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startJan 2002
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Investigators
- Aviram Nissan, MD, Principal investigator, Hadassah Medical OrganizationAlexander Stojadinovic, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571077
- Sponsor's protocol ID
- 1-31-7-02
- Other IDs
- EIS-T-02
- Status last verified
- Dec 2007
- First submitted
- 10 Dec 2007
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Nissan A, Peoples GE, Abu-Wasel B, Adair CF, Prus D, Howard RS, Lenington SG, Fields SI, Freund HR, Peretz T, Burch HB, Shriver CD, Stojadinovic A. Prospective trial evaluating electrical impedance scanning of thyroid nodules before thyroidectomy: final results. Ann Surg. 2008 May;247(5):843-53. doi: 10.1097/SLA.0b013e318165c757.
PubMed 18438123
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT00571077
- Acronym / sponsor ID
- 1-31-7-02
- Conditions
- Thyroid Neoplasms, Thyroid Nodules
- Keywords
- Thyroid neoplasms, thyroid nodules, electrical impedance scanning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Study start
- Jan 2002
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Dec 2007 (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.
Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan. Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be compared with final histopathology.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Electrical Impedance Scanning (EIS) of the Thyroid glandThis is a a single arm study evaluating the efficacy and accuracy of EIS in detecting malignant thyroid nodules. PAtients with thyroid nodules scheduled for surgery will undergo EIS examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 with thyroid nodules scheduled for surgery.
Key inclusion criteria (1 listed)
- Patients over the age of 18 with thyroid nodules scheduled for surgery.
Key exclusion criteria (2 listed)
- Pregnant patients
- PAtients with electrical powered devices (cardiac pacemakers)
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 |
|---|---|---|
| Electrical Impedance Scanning (EIS) of the Thyroid glandPatients will be examined in the supine position. A cylinder electrode conveying 2.5V electrical current will be held by the patient. The patient will be scanned by a probe (similar to an ultrasound probe. The examination takes 5 minutes and there is no risk or discomfort. | Device | A |
Primary outcome
Sensitivity and specificity of EIS
Time frame: 5 years
1 secondary outcome
NPV and PPV of EIS of the thyroid
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
- Derived from this study: PubMed 18438123Nissan A, Peoples GE, Abu-Wasel B, Adair CF, Prus D, Howard RS, Lenington SG, Fields SI, Freund HR, Peretz T, Burch HB, Shriver CD, Stojadinovic A. Prospective trial evaluating electrical impedance scanning of thyroid nodules before thyroidectomy: final results. Ann Surg. 2008 May;247(5):843-53. doi: 10.1097/SLA.0b013e318165c757.
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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.
Aviram Nissan, MD principal investigator
Hadassah Medical Organization
Alexander Stojadinovic, MD principal investigator
Walter Reed Army Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Neoplasms and Thyroid Nodules, run by Hadassah Medical Organization at 2 sites in 2 countries.
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 2 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: finished, as of the sponsor's last update on 13 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of EIS (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571077, which also lists 1 linked publication.
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 13 May 2008.