Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731531
Status:
RECRUITING
Last Update Posted:
2023-02-16
First Post:
2022-11-14
Brief Title:
EGG Test as a Predictor for an Individual Response to Treatment by Various Bariatric Procedures
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
Gastric Myoelectric Activity With Water Load Satiety Test as a Predictor of Individual Successful Response to Treatment by Various Bariatric Procedures
Status:
RECRUITING
Status Verified Date:
2023-02
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:
Total body weight loss TBWL after bariatric endoscopy BE is variable Gastric emptying may be normal rapid or delayed in patients with obesity and be a factor in variable BE outcomes Gastric myoelectrical activity GMA reflects gastric pacemaker activity which controls gastric contractions The non-invasive electrogastrogramEGG uses standard electrodes positioned on the abdominal surface to record GMA The investigators postulate that GMA patterns recorded with EGG will reflect subgroups in regards to stomach electrical physiology in obesity and that these subgroups will be useful in selecting patients for various BE procedures to maximize success of the procedures
Detailed Description:
Electrogastrography is a non-invasive method of recording GMA that is used to diagnose gastric dysrythmias in patients with intractable chronic nausea and vomiting gastroparesis and gastroesophageal reflux
Bariatric Techniques 3 categories 1restrictive2 mal absorptive 3mixed Bariatric endoscopy techniques have emerged as safe and effective treatment that include restrictive endoscopic techniques Intragastric balloons or endoscopic sleeve gastroplastyESGprimary surgery obesity endoluminal POSE or Endo-sleeve GESP or POSE 20 procedures malabsorptive techniques endoluminal bypass endobarrierduodenal mucosa resurfacing extraction methods Aspire electrical stimulation gastric pacemaker vagal blockage and other procedures
Weight loss and long-term maintenance may be conditioned by changes in GMA as well as by anatomical modifications induced by the bariatric procedure
Since anatomical modifications of the stomach by the BE procedures are related to weight loss The purpose is to determine whether different procedures to reduce gastric capacity will result in substantial changes in GMA and in the water load volume ingested No studies that have studied obese population before and after such BE procedures are available
Therefore whether obese patients have the GMA that is similar to those with functional dyspepsia and normal weight Also the usefulness of electrogastrography as a new tool to customize choice of Bariatric therapies by determining success or failure based on GMA and WLST results has not been studied GMA measures the normal or depleted gastric ICCs and the WLST measures gastric capacity objective measures that may be important to predict success of Bariatric procedures and thus to help with patient selection to maximize efficacy and minimize side effects
Demonstrate the usefulness of EGG meizuring the GMA by identifying subtypes with the Water Load Satiety Test WLST in obese adults to predict individual successful responses to BE treatments Intragastric Balloon IGB placement and Apollo Endoscopic Sleeve Gastroplasty ESG method
Bariatric Techniques 3 categories 1restrictive2 mal absorptive 3mixed Bariatric endoscopy techniques have emerged as safe and effective treatment that include restrictive endoscopic techniques Intragastric balloons or endoscopic sleeve gastroplastyESGprimary surgery obesity endoluminal POSE or Endo-sleeve GESP or POSE 20 procedures malabsorptive techniques endoluminal bypass endobarrierduodenal mucosa resurfacing extraction methods Aspire electrical stimulation gastric pacemaker vagal blockage and other procedures
Weight loss and long-term maintenance may be conditioned by changes in GMA as well as by anatomical modifications induced by the bariatric procedure
Since anatomical modifications of the stomach by the BE procedures are related to weight loss The purpose is to determine whether different procedures to reduce gastric capacity will result in substantial changes in GMA and in the water load volume ingested No studies that have studied obese population before and after such BE procedures are available
Therefore whether obese patients have the GMA that is similar to those with functional dyspepsia and normal weight Also the usefulness of electrogastrography as a new tool to customize choice of Bariatric therapies by determining success or failure based on GMA and WLST results has not been studied GMA measures the normal or depleted gastric ICCs and the WLST measures gastric capacity objective measures that may be important to predict success of Bariatric procedures and thus to help with patient selection to maximize efficacy and minimize side effects
Demonstrate the usefulness of EGG meizuring the GMA by identifying subtypes with the Water Load Satiety Test WLST in obese adults to predict individual successful responses to BE treatments Intragastric Balloon IGB placement and Apollo Endoscopic Sleeve Gastroplasty ESG method
Study Oversight
Has Oversight DMC:
None
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?:
None