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

NCT02410798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-07-20

Study results available
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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).

Conditions

  • Diaphragm Pacing

Interventions

DEVICE

TransLoc electrode

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

Sponsors & Collaborators

  • Synapse Biomedical

    lead INDUSTRY

Principal Investigators

  • Raymond Onders, MD · University Hospitals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02410798 on ClinicalTrials.gov