Describe the study in brief This is a single arm, over, double blind, single centre, multi-centre, randomised clinical investigation designed to examine the (safety performance) of the XXX device in patients with XXX disease/condition. – X number of patients will be enrolled to undergo the procedures detailed in this clinical investigational plan using XXX device. See schedule of events, appendix XX. Summary description of investigational device Provide a summary of the investigational device and its intended purpose. Design/pictures of device if available would be beneficial to include here. Manufacturer of the investigational device Provide information concerning the manufacturer of the device. Name: Address: Contact tel: Provide a summary of the name or number of the model/type, including software version and accessories, if any, to allow full identification of the device. Traceability Provide a description of how the traceability of the investigational devices will be achieved during and the clinical investigation, e.g. assignment of lot numbers, batch numbers or serial numbers. Intended purpose Provide a description of the intended purpose of the investigational device in the proposed clinical investigation. Populations and indications Provide a description of the populations and indications for which the investigational device is intended. Description of the investigational device Provide a description of the medical device, including any materials that will be in contact with tissues or body fluids (this will include details of any medicinal products, human or animal tissues or their derivatives, or other biologically active substances).
Describe the study in brief This is a single arm, over, double blind, single centre, multi-centre, randomised clinical investigation designed to examine the (safety – performance) of the XXX device in patients with XXX disease/condition. X number of patients will be enrolled to undergo the procedures detailed in this clinical investigational plan using XXX device. See schedule of events, appendix XX. Summary description of investigational device Provide a summary of the investigational device and its intended purpose. Design/pictures of device if available would be beneficial to include here. Manufacturer of the investigational device Provide information concerning the manufacturer of the device. Name: Address: Contact tel: Provide a summary of the name or number of the model/type, including software version and accessories, if any, to allow full identification of the device. Traceability Provide a description of how the traceability of the investigational devices will be achieved during and the clinical investigation, e.g. assignment of lot numbers, batch numbers or serial numbers. Intended purpose Provide a description of the intended purpose of the investigational device in the proposed clinical investigation. Populations and indications Provide a description of the populations and indications for which the investigational device is intended. Description of the investigational device Provide a description of the medical device, including any materials that will be in contact with tissues or body fluids (this will include details of any medicinal products, human or animal tissues or their derivatives, or other biologically active substances).
mu-app-01-clinical-investigational-plan-cip.docx