HR-EGG in Medically Refractory Gastroparesis

NCT05789511 | Unknown FDA Device

• 1 other identifier: 210461
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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. 1.Assess for the presence of gastric dysarrythmias in lung transplantation population as compared to alternative etiologies of gastroparesis
2. 2.Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
3. 3.Assess alterations in gastric dysarrthmias following pyloric interventions including G-POEM.

Conditions

Gastroparesis; Lung Transplant; Complications

Keywords

Gastroparesis; Post- Lung Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sub-type the specific bioelectrical abnormalities to assess which patterns are associated with symptoms and abnormal emptying across all subjects

  2 years

• Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy

  2 years

• Assess alterations in gastric dysarrythmias following pyloric interventions including G-POEM

  2 years

Study Arms (2)

Medically refractory Non-transplanted gastroparesis

Etiology of gastroparesis deemed on clinical grounds to NOT be secondary to lung transplantation process ( diabetes, post-surgery, idiopathic, neuromuscular etc.) Gastroparesis defined as \> 10% radiotracer remains in the stomach after 4 hour gastric scintigraphy study. Medically refractory is defined as lack of clinical response to trial of diet and lifestyle modifications such as small frequent low fat and low fiber meals and trial or contraindications to prokinetic medications for the treatment of gastroparesis Case Cohort: Assessment of HR-EGG comparing controls (non lung transplant induced gastroparesis) vs lung transplant induced gastroparesis Investigators will further categorize patients into sub- groups based on HR-EGG phenotypes:, such as High Frequency, Low Frequency, High Amplitude, Low Amplitude, Continuous Symptoms, Sensorimotor Symptoms, Mixed Symptoms and Normal on Day.

Device: High Resolution Electrogastography

Medically refractory Post Lung transplant gastroparesis

Etiology of gastroparesis deemed on clinical grounds to be secondary to lung transplantation process. Gastroparesis defined as \> 10% radiotracer remains in the stomach after 4 hour gastric scintigraphy study. Medically refractory is defined as lack of clinical response to trial of diet and lifestyle modifications such as small frequent low fat and low fiber meals and trial or contraindications to prokinetic medications for the treatment of gastroparesis Case Cohort: Assessment of HR-EGG comparing controls (non lung transplant induced gastroparesis) vs lung transplant induced gastroparesis Investigators will further categorize patients into sub- groups based on HR-EGG phenotypes:, such as High Frequency, Low Frequency, High Amplitude, Low Amplitude, Continuous Symptoms, Sensorimotor Symptoms, Mixed Symptoms and Normal on Day.

Device: High Resolution Electrogastography

Interventions

High Resolution Electrogastography DEVICE

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

Also known as: body surface gastric mapping

Medically refractory Non-transplanted gastroparesis; Medically refractory Post Lung transplant gastroparesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung Transplant induced gastroparesis body surface gastric mapping via the HR-EGG will be compared to non-lung transplant induced gastroparesis patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• Baylor College of Medicine: collaborator
• Stanford University: collaborator

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

University of Virginia

Charlottesville, Virginia, 22905, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 25443873 BACKGROUND

• 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.

  PMID: 23147521 BACKGROUND

• 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.

  PMID: 31210711 BACKGROUND

• 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.

  PMID: 31626659 BACKGROUND

• 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.

  PMID: 25863217 BACKGROUND

• 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.

  PMID: 28213666 BACKGROUND

• 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.

  PMID: 29379448 BACKGROUND

• 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.

  PMID: 30176605 BACKGROUND

• 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.

  PMID: 27305668 BACKGROUND

• 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.

  PMID: 29568042 BACKGROUND

• 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.

  PMID: 31199249 BACKGROUND

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexander J Podboy, MD

CONTACT

4349242620; JFV6DE@virginia.edu

Joanna Faulconer

CONTACT

4349242620

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine, Gastroenterology and Hepatology

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: December 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

US (2)