Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04661215
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2020-12-03
Brief Title:
Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSAGS
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK073983 | NIH | None | httpsreporternihgovquickSearchU01DK073983 |
| U24DK074008 | NIH | None | None |
| U01DK073974 | NIH | None | None |
| U01DK074007 | NIH | None | None |
| U01DK074035 | NIH | None | None |
| U01DK073975 | NIH | None | None |
| U01DK112193 | NIH | None | None |