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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


NCT ID:

NCT02410798


Primary Contact:

Principal Investigator
Raymond Onders, MD
University Hospitals


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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