Fluorescence Optic Fiber Stereotactic Needle Ratiometer for Breast Tumor Diagnosis.
Abstract
Activities during the first year focused on engineering the optic fiber probe and needle, on the breadboard design of the fluorescence instrument and on establishing the clinical protocol and patient consent form that must be followed in the clinical feasibility study part of the project. Fabrication of the device and trials on patients could not be undertaken in the absence of approval by the cooperating clinic's (Mass. Gen. Hospital) Institutional Review Board ('IRB') The constraints on the progress of the approval centered around the careful and protracted review by the IRB which has just recently granted approval based on its acquiescence that the device is of nonsignificant risk ('NSR') for the intended application. Still awaited from the lRB are revisions in their Patient Consent Form to be resubmitted to the Human Use Review and Regulatory Affairs Division, HO, USARMRMC.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 1995
- Accession Number
- ADA303790
Entities
People
- Guichen C. Tang