Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Key facts
- Where
- Boston, Louisville, Philadelphia, Scottsdale, and Winston-Salem, United StatesSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT04661215, who can take part
Where in United States
- Massachusetts GeneralBoston, United StatesContact: Nir Bar, MDTaking people
- University of LouisvilleLouisville, United StatesContact: Bridget Cannon, RNTaking people
- Temple UniversityPhiladelphia, United StatesContact: Rona T CooperTaking people
- Mayo Clinic - ArizonaScottsdale, United StatesContact: Guillermo Barahona, PhDTaking people
- Wake Forest University Health SciencesWinston-Salem, United StatesContact: Baha Moshiree, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Johns Hopkins Bloomberg School of Public Health
- Trial code
- NCT04661215
- Record updated
- 3 April 2026
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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; 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: Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication; Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy); Abnormalities seen on a prior upper endoscopy placing patient at increased risk:; Ulcer of the esophagus, stomach, or duodenum; Esophageal varices; Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures; Prior inflammatory bowel disease, Crohn's; Known history of achalasia or esophageal stricture; Known history of physiological or mechanical GI obstruction; 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; Individuals with contraindications for endoscopy, including bleeding abnormalities; Allergy to eggs preventing sedation with propofol and/or gastric emptying test; History of any esophageal/gastric/pyloric injection of botulinum toxin; 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; Significant dysphagia; Patients on daily opioid use or >3 day/week use.