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
This trial accepts healthy volunteersQualifiers
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 population
The study population will be 150 adult men and women aged 18-85 years, located in the United States, 100 will have symptoms of gastroparesis, and 50 participants in the control group will be patients undergoing upper endoscopy for clinical evaluation of diarrhea, gastrointestinal (GI) bleed, or iron-deficiency anemia, or evaluation for bariatric surgery who do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) . Control group participants will not have Gastric Alimetry testing or water load satiety testing.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Symptoms of gastroparesis
Group B: Control participants
Trial outcomes
Primary outcomes
1
Distensibility of the pylorus
Distensibility of the pylorus will be calculated as the median of three measurements (not three different inflations) of distensibility (mm2/mmHg) of the pylorus pressure using the Endoflip balloon catheter at 50 mL volume
Time frame
BaselineSecondary outcomes
1
Opening diameter (mm) of the pylorus when 40 mL volume is introduced into the EF325N Endoflip™ measurement catheter.
diameter (mm) of the pylorus
Time frame
Baseline2
Opening diameter (mm) of the pylorus when 50 mL volume is introduced into the EF325N Endoflip™ measurement catheter.
diameter (mm) of the pylorus
Time frame
Baseline3
Cross Sectional Area(mm2) of the pylorus with 40 mL balloon volume
Cross Sectional Area (mm2) of the pylorus
Time frame
Baseline4
Cross Sectional Area(mm2) of the pylorus with 50 mL balloon volume
Cross Sectional Area (mm2) of the pylorus
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
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