Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

Not yet recruiting

• Conditions: Idiopathic Gastric Motility Disorder; Diabetic Gastroparesis; Gastroparesis

• Registration Number: NCT04661215
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Detailed Description

Study Description: This is a multi-center, prospective, observational study to assess pyloric sphincter abnormalities in patients with symptoms of gastroparesis (both delayed and normal gastric emptying) and control participants without symptoms of gastroparesis using the commercially available, FDA approved endoluminal functional luminal imaging probe (Endoflip™) catheter, which measures diameter, cross-sectional area, pressure, compliance, and distensibility of gastrointestinal sphincter muscles.

This study will assess lower esophageal and pyloric sphincter diameter, CSA, pressure, distensibility, and compliance in patients with symptoms of gastroparesis and delayed gastric emptying, patients with symptoms of gastroparesis but with normal gastric emptying, and normal control participants. The protocol will also include a water load satiety test and use Gastric Alimetry™ System that assesses gastric myoelectrical activity in symptomatic participants but not control participants.

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Start: 2025-05-28
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distensibility of the pylorus	Baseline	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

Secondary Outcome Measures

Name	Time	Method
Opening diameter (mm) of the pylorus when 40 mL volume is introduced into the EF325N Endoflip™ measurement catheter.	Baseline	diameter (mm) of the pylorus
Opening diameter (mm) of the pylorus when 50 mL volume is introduced into the EF325N Endoflip™ measurement catheter.	Baseline	diameter (mm) of the pylorus
Cross Sectional Area(mm2) of the pylorus with 40 mL balloon volume	Baseline	Cross Sectional Area (mm2) of the pylorus
Cross Sectional Area(mm2) of the pylorus with 50 mL balloon volume	Baseline	Cross Sectional Area (mm2) of the pylorus
Compliance (mm3/mmHg) of the pylorus with 40 mL balloon volume	Baseline	Compliance (mm3/mmHg) of the pylorus
Compliance (mm3/mmHg) of the pylorus with 50 mL balloon volume	Baseline	Compliance (mm3/mmHg) of the pylorus
Pressure (mmHg) of the pyloric sphincter	Baseline	Pressure (mmHg) of the pyloric sphincter

Trial Locations

Locations (6)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Massachusetts General; 🇺🇸 Boston, Massachusetts, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Tech University Health Science Center (TTUHSC); 🇺🇸 El Paso, Texas, United States