Medical device clinical trial

Successful recruitment for medical device clinical studies.

Inadequate subject enrollment represents a significant obstacle during a medical device clinical investigation. It can lead to costly delays and jeopardise the success of an entire device development project. This article discusses the importance of devising an effective subject recruitment strategy so that clinical and regulatory requirements can be met.

Medical device interoperability and data integration to clinical information systems: medical device data alignment.

Aligning and synchronizing data from disparate medical devices can be an impediment to interoperability with electronic medical record systems (EMR). While some medical devices support open standards-based data communication, like Health Level Seven (HL7), many medical devices still do not. Even when medical devices support open standards, terminology and units of measurement may not be consist...

Biocarbon ureterostomy device for urinary diversion. Multicenter clinical trial.

The bioCarbon ureterostomy device is a stomal prosthesis for upper tract urinary diversion that has had preliminary successes in animal and human trials in Europe and Peru. Implantation of a pure carbon stomal prosthesis offers the potential advantages of high biocompatibility, lack of encrustation, and elimination of stomal stenosis which is frequently associated with cutaneous ureterostomy. N...

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study

BACKGROUND A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS Hospital-based, ...

Validating Medical Device Packaging