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University of Minnesota Clinical Translational Science Institute IDE Clinical Protocol: Medical Device Investigational Plan A. Investigational Plan 1.0 Purpose of the Investigation 1.1 Name of investigational device: Specify the name of the investigational device. 1.2 Intended use of the investigational device: Summarize the intended use of the investigational device. 1.3 Objectives of the clinical investigation: 1.3.1 Primary objective. Describe the primary objective of the proposed clinical investigation of the device. For example, indicate if the proposed clinical investigation constitutes a: Feasibility study directed at or involving a(n): Initial evaluation of the device in humans or a certain clinical population;. Evaluation of potential safety issues associated with the use of the device Evaluation of device design; Assessing certain human factors (e.g., patient or operator) associated with the use of the device; or Other specified device characteristic or device application consideration. Pilot study to obtain preliminary data upon which to base a subsequent pivotal study of the device. 1.3.2 Secondary objective(s). Describe any secondary objective(s) of the proposed clinical investigation of the device. 1.4 Anticipated duration of the clinical investigation: Provide a best estimate of the number of months or years it will take to complete the proposed feasibility study of the device. 2.0 Clinical Protocol 2.1 Title of clinical protocol: Specify the title of the clinical study. 2.1.1 Protocol number. (Incorporate only if applicable) 2.1.2 Version number and date. Number supplemental applications consecutively and include the date of the current application. 2.2 Study design: 2.2.1 General study design. Describe the type/design (e.g., open-label, observational) of the proposed clinical study. 2.2.2 Study design schematic. Provide a schematic diagram of the study design,