Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Johns Hopkins Bloomberg School of Public Health
Summary
The overall objective of this study is to determine if there are pyloric sphincter abnormalities in patients with gastroparesis symptoms and determine how prevalent these abnormalities are using tests to assess the pyloric sphincter - endoluminal functional luminal imaging probe (Endoflip™), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.
Description
Study Description: This is a multi-center, prospective, observational study to assess pyloric sphincter abnormalities in patients with symptoms of gastroparesis (both delayed and normal gastric emptying) and control participants without symptoms of gastroparesis using the commercially available, FDA approved endoluminal functional luminal imaging probe (Endoflip™) catheter, which measures diameter, cross-sectional area, pressure, compliance, and distensibility of gastrointestinal sphincter muscles. This study will assess lower esophageal and pyloric sphincter diameter, CSA, pressure, distensi…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria FOR SYMPTOMATIC PARTICIPANTS: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 18-85 4. Symptoms of gastroparesis, either diabetic or idiopathic etiology 5. Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0 6. Individual will have had a prior 4-hour gastric emptying scintigraphy test performed for clinical evaluation within the last 6 months. This gastric emptying test would be done for clinica…
Locations (5)
- Mayo Clinic ArizonaScottsdale, Arizona
- University of LouisvilleLouisville, Kentucky
- Massachusetts GeneralBoston, Massachusetts
- Wake Forest University Health SciencesWinston-Salem, North Carolina
- Temple UniversityPhiladelphia, Pennsylvania