HR-EGG in Medically Refractory Gastroparesis

Gastroparesis Clinical Trial

Official title:

High Resolution Electrogastrography (HR-EGG) Assessment in Medically Refractory Gastroparesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789511
• Other study ID #: 210461
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: March 2023
• Source: University of Virginia
• Contact: Alexander J Podboy, MD
• Phone: 4349242620
• Email: JFV6DE[@]virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 pyloromyotomy/bypass) 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 stomach's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (age >17 years old) with medically refractory gastroparesis

Exclusion Criteria:

• Females who are pregnant or lactating (self-reported)

• History of skin allergies to skin adhesives or hydrogels

• History of extreme sensitivity to cosmetics or lotions

• Fragile skin vulnerable to skin tears

• Damaged epigastric skin (open wounds, rash, inflammation)

• Patients unable to remain in a relaxed reclined position for the test duration

• BMI > 35 obtained via chart review

Related Conditions & MeSH terms

• Gastroparesis
• Lung Transplant; Complications

Intervention

Device:
• High Resolution Electrogastography
a new generation 64- channel high-resolution electrogastrography recording technology by Alimetry Limited that is able to record and analyze body surface gastric mapping/ HR-EGG

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Baylor College of Medicine	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	Baylor College of Medicine, Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Agrusa AS, Gharibans AA, Allegra AA, Kunkel DC, Coleman TP. A Deep Convolutional Neural Network Approach to Classify Normal and Abnormal Gastric Slow Wave Initiation From the High Resolution Electrogastrogram. IEEE Trans Biomed Eng. 2020 Mar;67(3):854-867. doi: 10.1109/TBME.2019.2922235. Epub 2019 Jun 12. — View Citation

Angeli TR, Cheng LK, Du P, Wang TH, Bernard CE, Vannucchi MG, Faussone-Pellegrini MS, Lahr C, Vather R, Windsor JA, Farrugia G, Abell TL, O'Grady G. Loss of Interstitial Cells of Cajal and Patterns of Gastric Dysrhythmia in Patients With Chronic Unexplained Nausea and Vomiting. Gastroenterology. 2015 Jul;149(1):56-66.e5. doi: 10.1053/j.gastro.2015.04.003. Epub 2015 Apr 8. — View Citation

Berry R, Cheng LK, Du P, Paskaranandavadivel N, Angeli TR, Mayne T, Beban G, O'Grady G. Patterns of Abnormal Gastric Pacemaking After Sleeve Gastrectomy Defined by Laparoscopic High-Resolution Electrical Mapping. Obes Surg. 2017 Aug;27(8):1929-1937. doi: 10.1007/s11695-017-2597-6. — View Citation

Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13. — View Citation

Du P, Calder S, Angeli TR, Sathar S, Paskaranandavadivel N, O'Grady G, Cheng LK. Progress in Mathematical Modeling of Gastrointestinal Slow Wave Abnormalities. Front Physiol. 2018 Jan 15;8:1136. doi: 10.3389/fphys.2017.01136. eCollection 2017. — View Citation

Gharibans AA, Kim S, Kunkel D, Coleman TP. High-Resolution Electrogastrogram: A Novel, Noninvasive Method for Determining Gastric Slow-Wave Direction and Speed. IEEE Trans Biomed Eng. 2017 Apr;64(4):807-815. doi: 10.1109/TBME.2016.2579310. Epub 2016 Jun 9. — View Citation

Gharibans AA, Smarr BL, Kunkel DC, Kriegsfeld LJ, Mousa HM, Coleman TP. Artifact Rejection Methodology Enables Continuous, Noninvasive Measurement of Gastric Myoelectric Activity in Ambulatory Subjects. Sci Rep. 2018 Mar 22;8(1):5019. doi: 10.1038/s41598-018-23302-9. — View Citation

Hooft N, Smith M, Huang J, Bremner R, Walia R. Gastroparesis is common after lung transplantation and may be ameliorated by botulinum toxin-A injection of the pylorus. J Heart Lung Transplant. 2014 Dec;33(12):1314-6. doi: 10.1016/j.healun.2014.08.016. Epub 2014 Sep 6. No abstract available. — View Citation

Nanivadekar AC, Miller DM, Fulton S, Wong L, Ogren J, Chitnis G, McLaughlin B, Zhai S, Fisher LE, Yates BJ, Horn CC. Machine learning prediction of emesis and gastrointestinal state in ferrets. PLoS One. 2019 Oct 18;14(10):e0223279. doi: 10.1371/journal.pone.0223279. eCollection 2019. — View Citation

O'Grady G, Angeli TR, Paskaranandavadivel N, Erickson JC, Wells CI, Gharibans AA, Cheng LK, Du P. Methods for High-Resolution Electrical Mapping in the Gastrointestinal Tract. IEEE Rev Biomed Eng. 2019;12:287-302. doi: 10.1109/RBME.2018.2867555. Epub 2018 Aug 29. — View Citation

Podboy A, Hwang JH, Nguyen LA, Garcia P, Zikos TA, Kamal A, Triadafilopoulos G, Clarke JO. Gastric per-oral endoscopic myotomy: Current status and future directions. World J Gastroenterol. 2019 Jun 7;25(21):2581-2590. doi: 10.3748/wjg.v25.i21.2581. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the presence of gastric dysarrythmias in lung transplantation population compared to alternative etiologies of gastroparesis	Investigators will categorize patients into sub- groups based on HR-EGG phenotypes:, such as Low GA-RI, High Frequency, Low Frequency, High Amplitude, Low Amplitude, Continuous Symptoms, Sensorimotor Symptoms, Mixed Symptoms and Normal on Day.	2 years
Secondary	Sub-type the specific bioelectrical abnormalities to assess which patterns are associated with symptoms and abnormal emptying across all subjects		2 years
Secondary	Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy		2 years
Secondary	Assess alterations in gastric dysarrythmias following pyloric interventions including G-POEM		2 years