N/A
N=12
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
Diaphragm Pacing
Bottom Line
View on ClinicalTrials.gov: NCT02410798 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participant That Experience Adverse Procedure and/or Device Effects — 0 Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TransLoc electrode (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Synapse Biomedical
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant That Experience Adverse Procedure and/or Device Effects |
— | — |
| PRIMARY Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm |
12 | — |
| PRIMARY Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants |
137 | — |
| PRIMARY Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured. |
12 | — |
| PRIMARY Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed. |
12 | — |
| PRIMARY Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode |
12 | — |
| SECONDARY Comparison of Percentage of Predicted Tidal Volumes Measured. |
107 | — |
| SECONDARY Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW) |
12 | — |
| SECONDARY Number of Participants With Successful Measurement and Characterization of Diaphragm Activity. |
12 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT02410798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.