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

Synapse Biomedical

Status

Completed

Conditions

Diaphragm Pacing

Treatments

Device: TransLoc electrode

Study type

Interventional

Funder types

Industry

Identifiers

NCT02410798

CLIN 20-1000-0006

Details and patient eligibility

About

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).

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.