NCT04661215 · Johns Hopkins Bloomberg School of Public Health
Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
(PSAGS)
What this study 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- FOR SYMPTOMATIC PARTICIPANTS:
- 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
- Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
- Individual will have had a prior 4-hour gastric emptying scintigraphy test performed for clinical evaluation within the last 6 months. This gastric emptying test would be done for clinical evaluation and is not part of the research study. From these participants with gastroparesis symptoms, we will include those with delayed gastric emptying as well as those with normal gastric emptying.
- Participant must not initiate any new treatments until completion of the study procedures.
- Willingness to:
- Stop histamine 2 antagonists, prokinetics (e.g., metoclopramide, erythromycin, domperidone, prucalopride), narcotics, anticholinergics, constipation medications (over the counter laxatives, isotonic polyethylene glycol (PEG) electrolyte preparations (e.g. MiraLax), prescription laxatives (e.g. lubiprostone), proton pump inhibitors, cannabinoids, and cannabidiol (CBD) for 3 days prior to each visit;
- Abstain from food and water after midnight (at least for 8 hours) before the start of each visit until after the visit. INCLUSION CRITERIA FOR CONTROL PARTICIPANTS
- Provision of signed and dated informed consent form
- Male or female, aged 18 or older
- Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery.
- Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire.
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
- 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
- Scottsdale, Arizona
- Louisville, Kentucky
- Boston, Massachusetts
- Winston-Salem, North Carolina
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations