Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms (NCT04661215) | Clinical Trial Compass
RecruitingNot Applicable
Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
United States150 participantsStarted 2026-01-13
Plain-language 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 (Endoflipâ„¢), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetryâ„¢ System.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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:
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
What they're measuring
1
Distensibility of the pylorus
Timeframe: Baseline
Trial details
NCT IDNCT04661215
SponsorJohns Hopkins Bloomberg School of Public Health
✕. Abnormalities seen on a prior upper endoscopy placing patient at increased risk:
✕. 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