Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04503785
Status:
RECRUITING
Last Update Posted:
2020-08-07
First Post:
2018-03-22
Brief Title:
Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis
Detailed Description:
Gastrointestinal GI motility problems are very common in the general population Dysphagia difficulty swallowing is one of the most common issues in gastroenterology In many patients esophageal obstruction is not identified despite workup with upper endoscopy or barium swallow x-ray Patients are often referred to the Motility Laboratory for evaluation of non-obstructive dysphagia Transnasal esophageal manometry-impedance is a diagnostic test to measure the pressures and coordination of the esophagus during swallowing The Endolumenal Functional Lumen Imaging Probe EndoFLIP is another instrument used to measure the lumen distensibility of the esophagus and pylorus Both tests are FDA-approved and are currently being used in clinical practice However correlation of the results obtained from these tests with clinical syndromes and symptoms is not clearly understood Furthermore the relationship between esophageal impedance-manometry and EndoFLIP results has never been defined
The primary Aim is to develop a registry of patients undergoing esophageal manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital
The primary Aim is to develop a registry of patients undergoing esophageal manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital
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?:
None
Is an FDA AA801 Violation?:
None