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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00595179
Other study ID # 999908042
Secondary ID 08-DK-N042
Status Completed
Phase N/A
First received January 3, 2008
Last updated April 4, 2012
Start date December 2007
Est. completion date January 2012

Study information

Verified date April 2012
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Current assessment of organ tissue viability by surgeons in the operating room is limited to crude estimates such as overt physical examination, measurement of laboratory values and physical measurements of vascular flow and resistance. The ability to non-invasively measure tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an injured organ will survive. The recent development of real time infrared (IR) and Near Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of development, the application of infrared and NIRS technology holds great promise to permit the surgeon to better assess the viability of tissues in ways that have not been possible. We propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using data previously collected during recipient operations at the NIH.


Description:

Current assessment of organ tissue viability by surgeons in the operating room is limited to crude estimates such as overt physical examination, measurement of laboratory values and physical measurements of vascular flow and resistance. The ability to non-invasively measure tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an injured organ will survive. The recent development of real time infrared (IR) and Near Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of development, the application of infrared and NIRS technology holds great promise to permit the surgeon to better assess the viability of tissues in ways that have not been possible. We propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using data previously collected during recipient operations at the NIH.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date January 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility - INCLUSION CRITERIA:

NIH Transplant Reccipients of living related, living unrelated, and cadaveric kidney transplants who underwent intra-operative IR/NIRS imaging.

EXCLUSION CRITERIA:

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK), 9000 Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gorbach AM, Heiss J, Kufta C, Sato S, Fedio P, Kammerer WA, Solomon J, Oldfield EH. Intraoperative infrared functional imaging of human brain. Ann Neurol. 2003 Sep;54(3):297-309. — View Citation

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