Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789511
Status:
RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-03-16
Brief Title:
HR-EGG in Medically Refractory Gastroparesis
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
High Resolution Electrogastrography HR-EGG Assessment in Medically Refractory Gastroparesis
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to utilize a novel high resolution electrogastrography device to gauge if identification of gastric dysarrythmias can reliably identify patients that will respond to or will require definitive pyloric interventions such as a G-POEM procedure in patients with medically refractory gastroparesis
Aims
1 Assess for the presence of gastric dysarrythmias in lung transplantation population as compared to alternative etiologies of gastroparesis
2 Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
3 Assess alterations in gastric dysarrthmias following pyloric interventions including G-POEM
Patients will undergo two surface body surface gastric mapping via the HR-EGG before and after undergoing a gastric per oral endoscopic myotomy as standard clinical care for the treatment of medically refractory gastroparesis
Aims
1 Assess for the presence of gastric dysarrythmias in lung transplantation population as compared to alternative etiologies of gastroparesis
2 Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
3 Assess alterations in gastric dysarrthmias following pyloric interventions including G-POEM
Patients will undergo two surface body surface gastric mapping via the HR-EGG before and after undergoing a gastric per oral endoscopic myotomy as standard clinical care for the treatment of medically refractory gastroparesis
Detailed Description:
Gastroparesis is a chronic digestive disorder defined by the symptoms of nausea vomiting bloating and abdominal pain in the setting of objectively delayed gastric emptying without mechanical gastric outlet obstruction Gastroparesis is frequently identified after lung transplantation with incidence rates as high as 44 Gastroparesis after lung transplantation is of significant concern as complications directly related to gastroparesis specifically gastroesophageal reflux and aspiration have been linked to the development of bronchiolitis obliterans syndrome the primary cause of graft failure and the main cause of late morbidity and mortality following lung transplantation Effective long-term therapy for medically refractory post-lung transplant gastroparesis represents a significant therapeutic challenge Current therapies such as botulinum toxin injection or surgical pyloromyotomybypass are either limited by inconsistent efficacy or by their invasiveness However recent advances in endoscopic tunneling techniques have led to the development of gastric per-oral endoscopic myotomy G-POEM Initial reports of this technique for treatment of post-lung transplant gastroparesis are encouraging with excellent preliminary safety and efficacy data However currently there are no clinical endoscopic or radiographic parameters that reliably predict which patients will respond to G-POEM This is likely secondary to the multifactorial pathophysiology of gastroparesis Secondary to this there is an unmet need to develop a widely deployable screening tool that is i non-invasive ii able to reliably divide gastroparesis into pathophysiologic subgroups and iii be able to guide effective treatments
In a similar fashion to that of the brain and heart waves generated at the stomachs surface propagate to the skin via volume conduction These voltages can be measured with cutaneous electrodes via gastric electrophysiology EGG noninvasively However the EGG has not encountered widespread clinical adoption as the ability to both reliably and consistently differentiate gastrocutaneous spatial dysrhythmias has not been possible However a novel high-resolution EGG HR-EGG a multi-electrode array of 25 or more electrodes has been shown to capture slow waves with high spatial resolution and extract meaningful spatial as opposed to spectral features including the instantaneous slow wave direction at any given point in space This coupled with novel deep convolutional neural network CNN frameworks and artifact rejection methods have been able to reliably capture gastric myoelectricspatial abnormalities that correlate with symptom incidence and severity in gastroparesis patients
Currently a new generation of high-resolution electrogastrograms recording technology with 64-channel electrode array is being developed by Alimetry Limited that is able to provide body surface gastric mapping BSGM This BSGM is able to provide a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively such as frequency and pattern in high spatiotemporal detail The system also includes an App for tracking patient-reported symptoms throughout the test
Our goal is to utilize this proprietary device to gauge if identification of gastric dysarrythmias can reliably identify patients that will respond to or will require definitive pyloric interventions such as a G-POEM procedure
In a similar fashion to that of the brain and heart waves generated at the stomachs surface propagate to the skin via volume conduction These voltages can be measured with cutaneous electrodes via gastric electrophysiology EGG noninvasively However the EGG has not encountered widespread clinical adoption as the ability to both reliably and consistently differentiate gastrocutaneous spatial dysrhythmias has not been possible However a novel high-resolution EGG HR-EGG a multi-electrode array of 25 or more electrodes has been shown to capture slow waves with high spatial resolution and extract meaningful spatial as opposed to spectral features including the instantaneous slow wave direction at any given point in space This coupled with novel deep convolutional neural network CNN frameworks and artifact rejection methods have been able to reliably capture gastric myoelectricspatial abnormalities that correlate with symptom incidence and severity in gastroparesis patients
Currently a new generation of high-resolution electrogastrograms recording technology with 64-channel electrode array is being developed by Alimetry Limited that is able to provide body surface gastric mapping BSGM This BSGM is able to provide a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively such as frequency and pattern in high spatiotemporal detail The system also includes an App for tracking patient-reported symptoms throughout the test
Our goal is to utilize this proprietary device to gauge if identification of gastric dysarrythmias can reliably identify patients that will respond to or will require definitive pyloric interventions such as a G-POEM procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None