- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00868504
Measuring Temperatures of Tissues During Endoscopy
September 29, 2009 updated by: Sheba Medical Center
Measuring Temperatures of Tumors and Normal Tissues in the GI Tract, Using a Thermocouple Sheathed in a Catheter, in the Work Canal of an Endoscope
Previous studies have indicated that tumors are warmer than the surrounding tissues.
We want to ascertain that this is true for tumors in the GI tract.
If so, a thermal camera in an endoscope may aid the diagnosis of tumors.
The experiment entails inserting a cannula sheathed thermocouple into the work canal of an endoscope or a colonoscope.
The examining physician will bring the distal end to touch the tumors he finds and their adjacent tissues, noting their respective temperatures.
This experiment must be conducted before embarking on the complicated and costly project of producing a tiny thermal camera which will be able to navigate the GI tract.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arie Orenstein, Prof.
- Phone Number: +97235303114
- Email: gidi.arbel@sheba.health.gov.il
Study Locations
-
-
-
Tel Hashomer, Israel, 52621
- Recruiting
- Sheba Medical Center
-
Contact:
- Arie Orenstein, Prof.
- Phone Number: +97234303114
- Email: gidi.arbel@sheba.health.gov.il
-
Contact:
- Gidi Arbel, Dr.
- Phone Number: +972544838960
- Email: gidi.arbel@sheba.health.gov.il
-
Principal Investigator:
- Arie Orenstein, Prof.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who undergo endoscopy or colonoscopy.
Description
Inclusion Criteria:
- consenting adults
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
examined by endoscopy
Patients, examined by endoscopy, being screened for GI tract tumors
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference of temperature between tumors and adjacent tissues
Time Frame: immediate
|
immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arie Orenstein, Prof., Sheba Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Anticipated)
October 1, 2009
Study Completion (Anticipated)
November 1, 2009
Study Registration Dates
First Submitted
March 24, 2009
First Submitted That Met QC Criteria
March 24, 2009
First Posted (Estimate)
March 25, 2009
Study Record Updates
Last Update Posted (Estimate)
September 30, 2009
Last Update Submitted That Met QC Criteria
September 29, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-09-6887-AO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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