Diaphragm PacingNCT02410798
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
A study testing TransLoc electrode in people with Diaphragm Pacing, run by Synapse Biomedical at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Pacing
- What is being tested?
- TransLoc electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Feasibility Clinical Study to Investigate the Safety and Performance of TransLoc® Electrodes for Temporary Diaphragm Pacing in Patients Undergoing Surgical Procedures
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).
Read the 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
- Being tested
- TransLoc electrode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransLoc electrodeDevice
Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
| Study group | Role | What they receive |
|---|---|---|
| TransLoc electrode | Experimental | Electrode placement Receives: Device: TransLoc electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant That Experience Adverse Procedure and/or Device Effects
All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
Measured: Implantation through hospital discharge or Day 7, whichever comes first.
Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm
Successful placement of two TransLoc electrodes in each hemi-diaphragm of the study participants during the operative procedure. Success was the ability to perform stimulation postoperatively using the implanted electrodes to effectively stimulate the patients for ventilation as evidenced by the ability to successfully achieve the predicted tidal volume.
Measured: Postoperatively on Day 1
Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants
Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant.
Measured: Postoperatively Day 1
Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.
Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants.
Measured: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.
Electrode stability was determined by using the electrodes to record tracings of the diaphragm EMG daily for at least a 10 minute period. The tracings were reviewed to determine diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any. The recordings also confirmed electrode stability (non-displacement and electrical integrity) during the period of temporary implantation.
Measured: Postop Day 1 through hospital discharge or 7 days, whichever comes first
Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode
Number of study participants in which TransLoc electrodes were removed intact without device fragmentation or the occurrence of device or procedure related adverse events. Removal was performed by the healthcare provider by pulling electrodes from the percutaneous entry point. This was done in a similar fashion as a temporary cardiac pacing wire with a slow steady pull in a straight non oblique line.
Measured: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Secondary outcomes (3)
Comparison of Percentage of Predicted Tidal Volumes Measured.
Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm.
Measured: Postop Day 1
Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)
Number of participants in which stimulation successfully achieves acceptable tidal volumes of at least 6cc/kg of predicted body weight (PBW). This predicted tidal volume measurement is based on the NIH NHLBI ARDS Clinical Network (ARDSnet) MV protocol criteria for Acute Respiratory Lung Syndrome (ARDS) protection resulting from the ALVELOI study.
Measured: Postop Day 1
Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.
Characterization of diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any for each study participant.
Measured: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diaphragm PacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synapse Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond Onders, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410798
- Sponsor's protocol ID
- CLIN 20-1000-0006
- Status last verified
- Jun 2021
- First submitted
- 2 Apr 2015
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Clinical Study to Investigate the Safety and Performance of TransLoc® Electrodes for Temporary Diaphragm Pacing in Patients Undergoing Surgical Procedures
- ClinicalTrials.gov ID
- NCT02410798
- Acronym / sponsor ID
- CLIN 20-1000-0006
- Conditions
- Diaphragm Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Synapse BiomedicalIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TransLoc electrode | Experimental | Device: TransLoc electrodeElectrode placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransLoc electrodePatients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery. | Device | TransLoc electrode |
Primary outcome
Number of Participant That Experience Adverse Procedure and/or Device Effects
Time frame: Implantation through hospital discharge or Day 7, whichever comes first.
All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm
Time frame: Postoperatively on Day 1
Successful placement of two TransLoc electrodes in each hemi-diaphragm of the study participants during the operative procedure. Success was the ability to perform stimulation postoperatively using the implanted electrodes to effectively stimulate the patients for ventilation as evidenced by the ability to successfully achieve the predicted tidal volume.
Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants
Time frame: Postoperatively Day 1
Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant.
Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants.
Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.
Time frame: Postop Day 1 through hospital discharge or 7 days, whichever comes first
Electrode stability was determined by using the electrodes to record tracings of the diaphragm EMG daily for at least a 10 minute period. The tracings were reviewed to determine diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any. The recordings also confirmed electrode stability (non-displacement and electrical integrity) during the period of temporary implantation.
Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Number of study participants in which TransLoc electrodes were removed intact without device fragmentation or the occurrence of device or procedure related adverse events. Removal was performed by the healthcare provider by pulling electrodes from the percutaneous entry point. This was done in a similar fashion as a temporary cardiac pacing wire with a slow steady pull in a straight non oblique line.
3 secondary outcomes
Comparison of Percentage of Predicted Tidal Volumes Measured.
Time frame: Postop Day 1
Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)
Time frame: Postop Day 1
Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diaphragm Pacing
RecruitingObservational study
International Congenital Central Hypoventilation Syndrome (CCHS) Registry and CCHS SHARE
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Effects of Combined Thoracic and Diaphragmatic Breathing on Cognitive and Psycho-Physiological Functions
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Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach
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Personalized Ultrasound-Guided External Diaphragm Pacing to Improve Outcomes in Invasive Mechanically Ventilated Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Onders, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransLoc electrode in people with Diaphragm Pacing, run by Synapse Biomedical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant That Experience Adverse Procedure and/or Device Effects (time frame: Implantation through hospital discharge or Day 7, whichever comes first.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.