Chronic Obstructive Airway DiseaseNCT02411383
Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation
A study testing NeuRx Diaphragm Pacing System in people with Chronic Obstructive Airway Disease, run by Synapse Biomedical at 1 site in Belgium.
Trial summary
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Airway Disease
- What is being tested?
- NeuRx Diaphragm Pacing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is undergoing bilateral lung transplantation
- Signed written informed consent has been obtained prior to any study related procedure
Who cannot join
- Diaphragm malformation which makes the electrode insertion impossible
- Presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma
- Participation in other clinical studies that could interfere with the results in the ongoing study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-centre, Open-label Clinical Study to Investigate the Safety and Performance of the NeuRx Diaphragm Pacing System (DPS) in Patients Undergoing Bilateral Lung Transplantation
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant.
Read the detailed description
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant. The objectives are to evaluate the safety and technical performance of DPS by assessing:
- the immediate safety and technical surgical results of implantation
- the safety and tolerability of use and removal until patient discharge from the Intensive Care Unit (ICU) or hospital
- the effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG)
- Conditions
- Chronic Obstructive Airway Disease
- Being tested
- NeuRx Diaphragm Pacing System
- Keywords
- Diaphragm pacing, Respiratory assistance, Lung transplant
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuRx Diaphragm Pacing SystemDevice
NeuRx Diaphragm Pacing System electrodes are placed in the diaphragm during lung transplant surgery. The diaphragm will be continually paced until the patient is free from the ventilator or the patient is discharged from the ICU whichever. Diaphragm measurements are taken daily to assess tolerability and pacing success.
| Study group | Role | What they receive |
|---|---|---|
| NeuRx Diaphragm Pacing System (DPS)® | Experimental | The NeuRx Diaphragm Pacing System (DPS)® is placed in the diaphragm during lung transplant. Receives: Device: NeuRx Diaphragm Pacing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Daily assessment of device or procedure-related adverse events until patient discharge.
Measured: 30 days
Tolerability: Patient withdrawal from treatment.
Measured: 30 days
Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.
Measured: 30 days
Secondary outcomes (1)
Composite endpoint
Effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG).
Measured: 30 days
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 startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airway DiseaseStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synapse Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dries Testelmans, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411383
- Sponsor's protocol ID
- CLIN 20-1000-0001
- Status last verified
- Apr 2016
- First submitted
- 2 Apr 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-centre, Open-label Clinical Study to Investigate the Safety and Performance of the NeuRx Diaphragm Pacing System (DPS) in Patients Undergoing Bilateral Lung Transplantation
- ClinicalTrials.gov ID
- NCT02411383
- Acronym / sponsor ID
- CLIN 20-1000-0001
- Conditions
- Chronic Obstructive Airway Disease
- Keywords
- Diaphragm pacing, Respiratory assistance, Lung transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Synapse BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant.
Detailed description
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant. The objectives are to evaluate the safety and technical performance of DPS by assessing:
- the immediate safety and technical surgical results of implantation
- the safety and tolerability of use and removal until patient discharge from the Intensive Care Unit (ICU) or hospital
- the effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeuRx Diaphragm Pacing System (DPS)® | Experimental | Device: NeuRx Diaphragm Pacing SystemThe NeuRx Diaphragm Pacing System (DPS)® is placed in the diaphragm during lung transplant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is undergoing bilateral lung transplantation
- Signed written informed consent has been obtained prior to any study related procedure
Key exclusion criteria (3 listed)
- Diaphragm malformation which makes the electrode insertion impossible
- Presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma
- Participation in other clinical studies that could interfere with the results in the ongoing 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 |
|---|---|---|
| NeuRx Diaphragm Pacing SystemNeuRx Diaphragm Pacing System electrodes are placed in the diaphragm during lung transplant surgery. The diaphragm will be continually paced until the patient is free from the ventilator or the patient is discharged from the ICU whichever. Diaphragm measurements are taken daily to assess tolerability and pacing success. | Device | NeuRx Diaphragm Pacing System (DPS)® |
Primary outcome
Safety: Daily assessment of device or procedure-related adverse events until patient discharge.
Time frame: 30 days
Tolerability: Patient withdrawal from treatment.
Time frame: 30 days
Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.
Time frame: 30 days
1 secondary outcome
Composite endpoint
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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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.
Dries Testelmans, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuRx Diaphragm Pacing System in people with Chronic Obstructive Airway Disease, run by Synapse Biomedical at 1 site in Belgium.
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 2 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 13 Apr 2016. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: Daily assessment of device or procedure-related adverse events until patient discharge. (time frame: 30 days). The study lists 3 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 13 Apr 2016.