Measuring Temperatures of Tissues During Endoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00868504
First received: March 24, 2009
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Carcinoma, Undifferentiated
Other: no intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Difference of temperature between tumors and adjacent tissues [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
examined by endoscopy
Patients, examined by endoscopy, being screened for GI tract tumors
Other: no intervention
no intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who undergo endoscopy or colonoscopy.

Criteria

Inclusion Criteria:

  • consenting adults

Exclusion Criteria:

  • none
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868504

Contacts
Contact: Arie Orenstein, Prof. +97235303114 gidi.arbel@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Arie Orenstein, Prof.    +97234303114    gidi.arbel@sheba.health.gov.il   
Contact: Gidi Arbel, Dr.    +972544838960    gidi.arbel@sheba.health.gov.il   
Principal Investigator: Arie Orenstein, Prof.         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Arie Orenstein, Prof. Sheba Medical Center
  More Information

Publications:
Responsible Party: Prof. Arie Orenstein , Director Advanced Technologies Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00868504     History of Changes
Other Study ID Numbers: SHEBA-09-6887-AO-CTIL
Study First Received: March 24, 2009
Last Updated: September 29, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
GI tract
Tumors
Temperatures

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014