Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, aged 18-85
Symptoms of gastroparesis, either diabetic or idiopathic etiology
Disqualifiers
Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication.
Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy)
Known history of achalasia or esophageal stricture
Known history of physiological or mechanical GI obstruction
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsLocations
5Mayo Clinic Arizona85259, ScottsdaleArizona, United States
University of Louisville40202, LouisvilleKentucky, United States
Massachusetts General02114, BostonMassachusetts, United States
Wake Forest University Health Sciences27157, Winston-SalemNorth Carolina, United States
Sponsors and collaborators
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Massachusetts General Hospital
Collaborator
Temple University
Collaborator
University of Louisville
Collaborator
Wake Forest University
Collaborator
Mayo Clinic
Collaborator
Source ClinicalTrials.gov