Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-17 @ 8:58 PM
Study NCT ID:
NCT05624034
Status:
UNKNOWN
Last Update Posted:
2022-11-21
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study the EGG Abnormalities in Healthy Subjects and in Patients With Idiopathic and Diabetic Gastroparesis.
Sponsor:
Asian Institute of Gastroenterology, India
Organization:
Study Overview
Official Title:
To Study the Electrogastrography [EGG]Abnormalities in Healthy Subjects and in Patients With Idiopathic and Diabetic Gastroparesis: A Prospective Single Center Study.
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
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:
Electrogastrogram (EGG) is a non-invasive method for recording myoelectric activities by placing electrodes on the abdomen surface. Many studies suggested EGG measures the gastric slow wave frequency effectively; the relative change in EGG signal amplitude would reflect the contractility of the stomach. Thus, this technique is used to study the pathophysiological processes of diseases such as functional dyspepsia and many more .
The present study aims to study the EGG pattern in healthy individuals in Indian population and the factors associated with it.
The present study aims to study the EGG pattern in healthy individuals in Indian population and the factors associated with it.
Detailed Description:
Electrogastrogram \[EGG\] is an authentic method to detect gastrointestinal diseases accompanied by gastric motility abnormalities . The present study would help to determine the normatic values of EGG in healthy population and EGG changes in patients with idiopathic gastroparesis. This pilot study would provide findings/abnormalities seen in study population and may be helpful in providing a comparative data for proper treatment and a better quality of life patients suffering from dyspepsia.
All the eligible subjects will undergo study procedure i.e. EGG. The study procedure will conduct as per standard study protocol. EGG is a non-invasive, painless method for the measurement of gastric myoelectrical activity. EGG takes around two hours to complete the procedure and no side effects reported. Following steps are included in the procedure
* Subject lie on back on a procedure table.
* Investigator or technician tapes electrodes to Subject's abdomen (belly). The electrodes are similar to those used for other tests, such as an ECG (electrocardiogram). The electrodes measure electrical signals coming from stomach muscles. They send the signals to a computer that records the signals as a graph.
* Investigator or technician records a test while Subject's stomach is empty. An hour later, Subject have something to eat and drink. Investigator or technician then records a second test. The test and electrodes are painless.
* The electrodes are removed. EGG test is completed at this point.
All the eligible subjects will undergo study procedure i.e. EGG. The study procedure will conduct as per standard study protocol. EGG is a non-invasive, painless method for the measurement of gastric myoelectrical activity. EGG takes around two hours to complete the procedure and no side effects reported. Following steps are included in the procedure
* Subject lie on back on a procedure table.
* Investigator or technician tapes electrodes to Subject's abdomen (belly). The electrodes are similar to those used for other tests, such as an ECG (electrocardiogram). The electrodes measure electrical signals coming from stomach muscles. They send the signals to a computer that records the signals as a graph.
* Investigator or technician records a test while Subject's stomach is empty. An hour later, Subject have something to eat and drink. Investigator or technician then records a second test. The test and electrodes are painless.
* The electrodes are removed. EGG test is completed at this point.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: