NCT02410798

Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures

Early Feasibility Clinical Study to Investigate the Safety and Performance of TransLoc® Electrodes for Temporary Diaphragm Pacing in Patients Undergoing Surgical Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Synapse Biomedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in the Intensive Care Unit (ICU).

Detailed description

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.

Conditions

• Diaphragm Pacing

Interventions

Type	Name	Description
DEVICE	TransLoc electrode	Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-04-08
• Last updated: 2021-07-20
• Results posted: 2021-07-20

Locations

1 site across 1 country: United States