NCT04661215 Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
| NCT ID | NCT04661215 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Gastroparesis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-01-13 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria FOR SYMPTOMATIC PARTICIPANTS: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 18-85 4. Symptoms of gastroparesis, either diabetic or idiopathic etiology 5. Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0 6. 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. 7. Participant must not initiate any new treatments until completion of the study procedures. 8. Willingness to: 1. 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; 2. 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 1. Provision of signed and dated informed consent form 2. Male or female, aged 18 or older 3. Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery. 4. Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire. EXCLUSION CRITERIA: 1. Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication. 2. Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy) 3. Known history of achalasia or esophageal stricture 4. Known history of physiological or mechanical GI obstruction 5. Abnormalities seen on a prior upper endoscopy placing patient at increased risk: * Ulcer of the esophagus, stomach, or duodenum * Esophageal varices 6. Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy. 7. Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc) 8. Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom 9. Acute or chronic renal insufficiency 10. Current eating disorders 11. Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures. 12. Individuals with contraindications for endoscopy, including bleeding abnormalities 13. Allergy to eggs preventing sedation with propofol and/or gastric emptying test 14. Significant dysphagia 15. Prior inflammatory bowel disease, Crohn's 16. History of any esophageal/gastric/pyloric injection of botulinum toxin 17. Patients on daily opioid use or \>3 day/week use 18. 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
Contact & Investigator
Pankaj Pasricha, MD
STUDY CHAIR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04661215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Gastroparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04661215 currently recruiting?
Yes, NCT04661215 is actively recruiting participants. Contact the research team at laura.miriel@jhu.edu for enrollment information.
Where is the NCT04661215 trial being conducted?
This trial is being conducted at Scottsdale, United States, Louisville, United States, Boston, United States, Winston-Salem, United States and 1 additional location.
Who is sponsoring the NCT04661215 clinical trial?
NCT04661215 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Pankaj Pasricha, MD at Mayo Clinic. The trial plans to enroll 150 participants.