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

NCT ID: NCT02410798

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TransLoc electrode

Electrode placement

Group Type: EXPERIMENTAL

TransLoc electrode

Intervention Type: DEVICE

Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.

Interventions

TransLoc electrode

Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synapse Biomedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Onders, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

University Hospital

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CLIN 20-1000-0006

Identifier Type: -

Identifier Source: org_study_id