🏛️ Verified NIH Record • Updated 2026-03-30

Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms (NCT04661215)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Johns Hopkins Bloomberg School of Public Health

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (21 items).

Location: Mayo Clinic Arizona — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • EXCLUSION CRITERIA:
  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

  • Mayo Clinic Arizona — Scottsdale, Arizona
  • University of Louisville — Louisville, Kentucky
  • Massachusetts General — Boston, Massachusetts
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina
  • Temple University — Philadelphia, Pennsylvania

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗