Actively Recruiting
Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2026-04-03
150
Participants Needed
5
Research Sites
65 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins Bloomberg School of Public Health
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for study duration
- Male or female aged 18 to 85 years
- Symptoms of gastroparesis, diabetic or idiopathic
- Gastroparesis Cardinal Symptom Index (GCSI) score of at least 2.0
- Prior 4-hour gastric emptying scintigraphy test within last 6 months
- No new treatments started until study completion
- Willingness to stop certain medications 3 days before visits and fast for at least 8 hours before visits
- Control participants must be 18 or older undergoing upper endoscopy for clinical reasons without significant upper GI symptoms
You will not qualify if you...
- Prior gut lumen surgery on esophagus or stomach, including Nissen fundoplication
- Prior surgery on pylorus (G-POEM, pyloroplasty, pyloromyotomy)
- History of achalasia or esophageal stricture
- History of physiological or mechanical GI obstruction
- Ulcers or esophageal varices found on prior endoscopy
- Severe chronic pulmonary disease or severe food retention increasing endoscopy risk
- Significant gastric or duodenal pathology causing dysmotility
- Other chronic diseases causing gastrointestinal symptoms
- Acute or chronic renal insufficiency
- Current eating disorders
- Pregnancy
- Contraindications for endoscopy including bleeding abnormalities
- Allergy to eggs affecting sedation or gastric emptying test
- Significant difficulty swallowing (dysphagia)
- History of inflammatory bowel disease or Crohn's
- Prior botulinum toxin injections in esophagus/stomach/pylorus
- Daily opioid use or use more than 3 days per week
- Use of GLP1 receptor agonists or SGLT2 or GIP-GLP combo drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
Massachusetts General
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
5
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
Research Team
L
Laura A Miriel, BS
CONTACT
E
Emily Mitchell, MS, MBA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here