Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Recruiting now
Conditions studied: Gastroparesis, Idiopathic Gastric Motility Disorder, Diabetic Gastroparesis
In brief
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.
Key facts
- Study ID
- NCT04661215
- Run by
- Johns Hopkins Bloomberg School of Public Health
- People needed
- 150
- Starts
- 2026-01-13
- Expected to finish
- 2027-04-15
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- 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
- Abnormalities seen on a prior upper endoscopy placing patient at increased risk:
- Ulcer of the esophagus, stomach, or duodenum
- Esophageal varices
- Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy.
- Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc)
- Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom
- Acute or chronic renal insufficiency
- Current eating disorders
- Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures.
- Individuals with contraindications for endoscopy, including bleeding abnormalities
- Allergy to eggs preventing sedation with propofol and/or gastric emptying test
- Significant dysphagia
- Prior inflammatory bowel disease, Crohn's
- History of any esophageal/gastric/pyloric injection of botulinum toxin
- Patients on daily opioid use or >3 day/week use
- Use of glucagon-like peptide 1 (GLP1) receptor agonists or Sodium-Glucose Transport Protein 2 (SGLT2); Gastric inhibitory polypeptide (GIP)- glucagon-like peptide (GLP) combo
Where it is running
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
- University of Louisville — Louisville, Kentucky, United States (enrolling)
- Massachusetts General — Boston, Massachusetts, United States (enrolling)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
- Temple University — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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