Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps
Implanted pacemaker, defibrillator, deep brain stimulator, or other implanted electronic devices in the brain or other documented clinically significant arrhythmias
Patients with active implanted medical device, a skull defect (such as, missing bone with no replacement), a shunt or bullet fragments; examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts
Have implanted cardiac pacemakers or defibrillators
Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain
Any contraindication to MRI including but not limited to the presence of a pacemaker/defibrillator or other implanted ferromagnetic device or an inability to lie prone
Implanted with heart pacemaker or other implanted electronic device
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus nerve stimulator, and other implanted electronic devices in the brain or the spinal cord.
Implanted hardware which limits treatment planning or delivery (determined by the investigator)
Patients with active implanted medical or electronic device or bullet fragments including pacemakers, defibrillators, deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, and programmable shunts
Patients with active implanted electronic devices in the brain or spinal cord such as programmable VP shunts, deep brain stimulators, vagus nerve stimulators, are not allowed
Prior history of hip, pelvic, or lumbosacral prosthesis or other implanted device
Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-MR conditional heart valves
Fewer than two acceptable sites exist for intramuscular (IM) injection and electroporation (EP) between the deltoid and lateral quadriceps muscles. Note: a site for injection/EP is not acceptable if there are tattoos or scars within cm of the proposed injection/EP site or if there is implanted metal within the same limb. Any device implanted in the chest (e.g. cardiac pacemaker or defibrillator) excludes the use of the deltoid muscle on the same side of the body.
The subject has an implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, history of allergic reaction/hypersensitivity to gadolinium)
Has implanted medical devices that pose high risks for colonization and cannot be easily removed
Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
Implanted medical device such as a pacemaker, defibrillator, deep brain stimulator, or vagus nerve stimulator, or documented significant arrhythmia at the discretion of the investigator
Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved
Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts)
Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
Implanted electronic medical device in the brain:
Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts), a skull defect (such as missing bone with no replacement), a shunt, or bullet fragments
Tattoos or scars within cm of the intended site of injection or if there is implanted metal within the same limb. Any device implanted in the chest (e.g., cardiac pacemaker or defibrillator) excludes the use of the deltoid muscle on the same side of the body;
Prior liver or heart transplantation or implanted cardiac mechanical assist device.
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus nerve stimulator, and other implanted electronic devices in the brain or the spinal cord
MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia or inability to lie flat for the duration of the study, etc.
Have any active implanted electronic device (e.g., pacemaker),
Have an implanted electronically charged medical device
implanted devices that cannot be easily removed
Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain.
Cardiac pacemaker or other implanted electronic devices
Patients with only totally implanted CVCs or ports are ineligible
No implanted medical devices or implanted metal in the head
Pacemaker or other electronic implanted device
Patients with cardiac pacemakers or other implanted electronic devices
Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)
Has an implanted electronically charged medical device
Pacemaker or other implanted device
Active implanted medical device (e.g., cardiac pacemakers, defibrillators) or patients connected to electronic life support devices or metallic devices that would interfere with BIS measurements.
Have a pacemaker or implanted device.
No contraindications to the performance of a magnetic resonance study:\r\n* The presence of an implanted metallic object such as a cardiac pacemaker or implantable\r\ndefibrillator\r\n* An implanted neural stimulator\r\n* Any ferromagnetic implants not deemed MRI-safe\r\n* Intra-ocular metallic foreign bodies\r\n* Severe claustrophobia\r\n* Pregnancy\r\n* Inability to perform an exercise test
An implanted pacemaker or cardiac defibrillator
No implanted metallic objects
The presence of an implanted pacemaker or implanted defibrillator device
Implanted medical device not described above that is not MRI-compatible
Presence of an implanted device that is incompatible with CT scanning
Active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps
The presence of an implanted pacemaker or implanted defibrillator device
Implanted medical device not described above that is not MRI-compatible
Patients with pacemakers or other implanted magnetic devices that may malfunction or move in the strong magnetic field
The presence of an implanted pacemaker or implanted defibrillator device
Implanted medical device not described above that is not MRI-compatible
have implanted prosthetic heart valve,
Subjects who have vascular access ports or other implanted devices rated as anything other than safe or conditional
Participants with an implanted device, prosthesis, or any other foreign body with ferromagnetic properties that would make them ineligible to undergo MRI examination
Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes
Subjects with a counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator)
Contraindications to MRI\r\n* Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips\r\n* The presence of an implanted pacemaker or implanted defibrillator device\r\n* Patients with contraindications for MRI due to embedded foreign metallic objects: bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient\r\n* Implanted medical device not described above that is not MRI-compatible\r\n* Known history of claustrophobia
Subjects who have vascular access ports or other implanted devices rated as anything other than Safe or Conditional
MRI contraindications include: \r\n* Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips \r\n* Patients with implanted pacemaker or implanted defibrillator device \r\n* Patients with contraindications for MRI due to embedded foreign metallic objects; bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient \r\n* Implanted medical device not described above that is not MRI-compatible \r\n* Known history of claustrophobia \r\n* Contrast contraindications not included since patients will not be receiving MRI or CT contrast as part of this study
Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effect of the Calypso System operation on these devices is unknown.
Current use of any implanted electronic stimulation device