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HR-EGG in Medically Refractory Gastroparesis

NCT05789511 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-03-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • University of Virginia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05789511 on ClinicalTrials.gov