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

Completed · Not applicable

Conditions studied: Diaphragm Pacing

In brief

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).

Key facts

Study ID

NCT02410798

Run by

Synapse Biomedical

People needed

12

Starts

2015-05-01

Expected to finish

2015-08-01

Last updated by the study team

2021-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospital — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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