Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT04096703
Status:
WITHDRAWN
Last Update Posted:
2022-03-04
First Post:
2019-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Idiopathic Esophagogastric Junction Outflow Obstruction
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Characterization of Lower Esophageal Sphincter Function in Idiopathic Esophagogastric Junction Outflow Obstruction and Clinical Response to Pneumatic Dilation
Status:
WITHDRAWN
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit participants for study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares two treatments for Idiopathic Esophagogastric Junction Outflow Obstruction: pneumatic dilation compared with expectant management, on symptoms and liquid barium emptying exams.
Detailed Description:
The objectives of this study are to address these gaps in knowledge by:
Performing a randomized controlled trial in patients with idiopathic EGJOO that compares treatment outcomes after pneumatic dilation versus expectant management (disease controls) (expectant management). And, determining rational physiological and objective measures of treatment response.
Performing a randomized controlled trial in patients with idiopathic EGJOO that compares treatment outcomes after pneumatic dilation versus expectant management (disease controls) (expectant management). And, determining rational physiological and objective measures of treatment response.
Study Oversight
Has Oversight DMC:
False
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?: