NCT04661215|RecruitingDMC
Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
PSAGS
Loading search results
PSAGS
Sponsor study identifier
Secondary identifiers
observational
150
1 country
5
Study Start
January 13, 2026
Actual (reported)Primary Completion
March 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2020
Actual (reported)December 10, 2020
Actual (reported)January 13, 2026
Actual (reported)March 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Distensibility of the pylorus
Distensibility of the pylorus will be calculated as the median of three measurements (not three different inflations) of distensibility (mm2/mmHg) of the pylorus pressure using the Endoflip balloon catheter at 50 mL volume
Baseline
Opening diameter (mm) of the pylorus when 40 mL volume is introduced into the EF325N Endoflip™ measurement catheter.
Baseline
Opening diameter (mm) of the pylorus when 50 mL volume is introduced into the EF325N Endoflip™ measurement catheter.
Baseline
Cross Sectional Area(mm2) of the pylorus with 40 mL balloon volume
Baseline
Cross Sectional Area(mm2) of the pylorus with 50 mL balloon volume
Baseline
Compliance (mm3/mmHg) of the pylorus with 40 mL balloon volume
Baseline
Participants with symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
Participants undergoing endoscopy for evaluation but without gastroparesis symptoms or gastroesophageal reflux symptoms. Score 1.0 or less (≤ 1 ) on the GCSI of Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) questionnaire
The study population will be 150 adult men and women aged 18-85 years, located in the United States, 100 will have symptoms of gastroparesis, and 50 participants in the control group will be patients undergoing upper endoscopy for clinical evaluation of diarrhea, gastrointestinal (GI) bleed, or iron-deficiency anemia, or evaluation for bariatric surgery who do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) . Control group participants will not have Gastric Alimetry testing or water load satiety testing.
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Fisher R, Cohen S. Physiological characteristics of the human pyloric sphincter. Gastroenterology. 1973 Jan;64(1):67-75. No abstract available.
Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov;127(5):1592-622. doi: 10.1053/j.gastro.2004.09.055.
Pankaj Pasricha, MD
Mayo Clinic
Henry Parkman, MD
Temple University
First Submitted
December 3, 2020
First Posted
December 10, 2020
Study Start
January 13, 2026
Actual (reported)Primary Completion
March 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Massachusetts General
Boston, Massachusetts, 02114, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Desipio J, Friedenberg FK, Korimilli A, Richter JE, Parkman HP, Fisher RS. High-resolution solid-state manometry of the antropyloroduodenal region. Neurogastroenterol Motil. 2007 Mar;19(3):188-95. doi: 10.1111/j.1365-2982.2006.00866.x.
Mearin F, Camilleri M, Malagelada JR. Pyloric dysfunction in diabetics with recurrent nausea and vomiting. Gastroenterology. 1986 Jun;90(6):1919-25. doi: 10.1016/0016-5085(86)90262-3.
Study Completion
April 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 3, 2026
Record last verified: 2026-03
Public use complete database will be submitted to the NIDDK Data Repository
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: