The overall goal of this feasibility study is to advance the development of NeuRx DPS for
the intended use of stimulating the diaphragm to provide respiratory assistance in patients
at risk of prolonged mechanical ventilation in the ICU. This is the first step to determine
the technical feasibility of the short-term TransLoc DPS electrode in humans.
This is a prospective, open-label, single-center study to examine the feasibility of the
TransLoc DPS electrode placement and removal. Twelve (12) subjects undergoing a surgical
procedure will receive the device (four electrodes) and will be followed until electrode
removal up to seven days post-procedure. Subjects will be selected from surgical candidates
undergoing laparoscopic, open abdominal, and open thoracic procedures.
The primary endpoints are identified to show the viability of the procedure and integrity of
the system through the placement, use, monitoring, and removal of the electrodes. The
secondary endpoints are identified to determine the effectiveness of electrode placement.
The long-term intent of these investigations is to avoid the effects of ventilator induced
diaphragm dysfunction (VIDD) and the associated complications and costs, and to improve the
quality of patient care.
- Patient is undergoing a surgical procedure with expected admission to the hospital.
- Patient is undergoing a laparoscopic, open abdominal, or open chest surgical
procedure that allows access to the diaphragm.
- Negative pregnancy test if the patient is a female of child-bearing potential.
- Patient is at least 18 years of age.
- Informed consent has been obtained from the patient or designated representative.
- Patient has an implanted cardiac defibrillator.
- Patient is pregnant or breastfeeding.
- The patient is involved in another clinical study that could influence the safety or
outcome measures of this study.