GastroparesisNCT05789511
HR-EGG in Medically Refractory Gastroparesis
An observational study of Gastroparesis and Lung Transplant; Complications, run by University of Virginia at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Lung Transplant; Complications
- What is being tested?
- High Resolution Electrogastography
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2022to Jun 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung Transplant induced gastroparesis body surface gastric mapping via the HR-EGG will be compared to non-lung transplant induced gastroparesis patients
Who may be able to join
- Adult patients (age >17 years old) with medically refractory gastroparesis
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Joanna Faulconer contact
United States2 sites, 2 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22905
Alexander J Podboy
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
Reena Chokshi
Salmaan A Jawaid
About this study
Official title: High Resolution Electrogastrography (HR-EGG) Assessment in Medically Refractory Gastroparesis
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:
Read more
- Assess for the presence of gastric dysarrythmias in lung transplantation population as compared to alternative etiologies of gastroparesis
- Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
- 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
Read the 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 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.
- Conditions
- Gastroparesis, Lung Transplant; Complications
- Being tested
- High Resolution Electrogastography
- Keywords
- Gastroparesis, Post- Lung Transplant
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution ElectrogastographyDevice
Also called body surface gastric mapping
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: High Resolution Electrogastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 years
Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
Measured: 2 years
Assess alterations in gastric dysarrythmias following pyloric interventions including G-POEM
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Dec 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, Stanford University
- Responsible party
- Principal investigator, Alexander Podboy, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789511
- Sponsor's protocol ID
- 210461
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 25443873Camilleri 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.
PubMed 23147521Podboy 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.
PubMed 31210711Nanivadekar 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.
PubMed 31626659Angeli 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.
PubMed 25863217Berry 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.
PubMed 28213666Du 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.
PubMed 29379448O'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.
PubMed 30176605Gharibans 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.
PubMed 27305668Gharibans 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.
PubMed 29568042Agrusa 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.
PubMed 31199249
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Electrogastrography (HR-EGG) Assessment in Medically Refractory Gastroparesis
- ClinicalTrials.gov ID
- NCT05789511
- Acronym / sponsor ID
- 210461
- Conditions
- Gastroparesis, Lung Transplant; Complications
- Keywords
- Gastroparesis, Post- Lung Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, Stanford University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 29 Mar 2023 (actual)
- 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.
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:
- Assess for the presence of gastric dysarrythmias in lung transplantation population as compared to alternative etiologies of gastroparesis
- Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
- 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medically refractory Non-transplanted gastroparesis | – | Device: High Resolution ElectrogastographyEtiology 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. |
| Medically refractory Post Lung transplant gastroparesis | – | Device: High Resolution ElectrogastographyEtiology 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung Transplant induced gastroparesis body surface gastric mapping via the HR-EGG will be compared to non-lung transplant induced gastroparesis patients
Key inclusion criteria (1 listed)
- Adult patients (age >17 years old) with medically refractory gastroparesis
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| High Resolution ElectrogastographyAlso: body surface gastric mappinga 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 | Device | Medically refractory Non-transplanted gastroparesis, Medically refractory Post Lung transplant gastroparesis |
Primary outcome
Assess the presence of gastric dysarrythmias in lung transplantation population compared to alternative etiologies of gastroparesis
Time frame: 2 years
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.
3 secondary outcomes
Sub-type the specific bioelectrical abnormalities to assess which patterns are associated with symptoms and abnormal emptying across all subjects
Time frame: 2 years
Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
Time frame: 2 years
Assess alterations in gastric dysarrythmias following pyloric interventions including G-POEM
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 25443873Hooft 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.
- Background: PubMed 23147521Camilleri 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.
- Background: PubMed 31210711Podboy 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.
- Background: PubMed 31626659Nanivadekar 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.
- Background: PubMed 25863217Angeli 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.
- Background: PubMed 28213666Berry 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.
- Background: PubMed 29379448Du 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.
- Background: PubMed 30176605O'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.
- Background: PubMed 27305668Gharibans 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.
- Background: PubMed 29568042Gharibans 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.
- Background: PubMed 31199249Agrusa 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.
- Individual participant dataSharing planned: Undecided
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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.
Joanna Faulconer contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Lung Transplant; Complications, run by University of Virginia at 2 sites in United States.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander J Podboy, MD (4349242620, JFV6DE@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the presence of gastric dysarrythmias in lung transplantation population compared to alternative etiologies of gastroparesis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05789511, which also lists 11 linked publications.
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 31 Mar 2023.