Recruiting

HR-EGG

Sponsor:

University of Virginia

Code:

NCT05789511

Conditions

Gastroparesis

Lung Transplant; Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Resolution Electrogastography

Study Details

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

Conditions

Gastroparesis

Lung Transplant; Complications

Study ID

NCT05789511

Start date

Dec 1, 2022

Status verified date

Mar, 2023

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Assess the presence of gastric dysarrythmias in lung transplantation population compared to alternative etiologies of gastroparesis [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Alexander J Podboy, MD

4349242620JFV6DE@virginia.edu

Joanna Faulconer

4349242620

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22905

More Information

Sponsor

University of Virginia

Last update posted

Mar 31, 2023

Last verified

Mar, 2023

Keywords

  • Gastroparesis
  • Post- Lung Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2023-03-31.