Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04771247
Status:
WITHDRAWN
Last Update Posted:
2021-09-28
First Post:
2021-02-23
Brief Title:
Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Endoscopic Cardiac Band Ligation CLEAR Without Sleeve Stenosis for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy LSG
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB approval withheld
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEAR
Brief Summary:
GERD is a prevalent condition worldwide estimated to be around 20-30 in North America Obesity is rapidly increasing with an estimated prevalence of 66 in the adult population in the United States Presently bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy LSG Although very effective for treating obesity some of these surgeries might cause deleterious effects regarding GERD due to anatomical modifications Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy Cardia Band Ligation Anti-reflux CLEAR procedure utilizes multiple band ligations at the cardia in a 270-degree fashion resulting in tissue necrosis and scar formation narrowing the GE junction and enhancing the flap valve system The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD
Detailed Description:
GERD is a prevalent condition worldwide estimated to be around 20-30 in North America Obesity is rapidly increasing with an estimated prevalence of 66 in the adult population in the United States GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 346 and erosive esophagitis 269 in people with BMI 30 Kgm2 Reflux is associated with complications such as esophagitis Barretts Esophagus and ultimately esophageal adenocarcinoma Presently bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities There are endoscopic and surgical bariatric interventions Bariatric surgery has been shown to be an effective and efficient means of achieving significant weight loss in obese individuals One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy LSG Although very effective for treating obesity some of these surgeries might cause deleterious effects regarding GERD due to anatomical modifications LSG can increase the incidence of GERD which may be explained from the changes in the angle of His and by increasing intragastric pressure Pharmacological therapy with proton pump inhibitors PPI H2 blockers and lifestyle changes are first line forms of treatment utilized to control the symptoms related to GERD However patients who use pharmacological treatment experience reduction in quality of life and seek alternative options Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy Moreover due to the anatomical changes associated with bariatric surgeries the traditional surgical and endoscopic techniques TIF Nissen Fundoplication used to treat GERD in the general population are not suitable for these patients With the current trend of an increase of bariatric surgery and thus GERD that arises after these surgeries new innovative techniques to treat GERD are needed especially in PPI averse or non-responsive patients Cardia Band Ligation Anti-reflux CLEAR procedure utilizes multiple band ligations at the cardia in a 270-degree fashion resulting in tissue necrosis and scar formation narrowing the GE junction and enhancing the flap valve system The investigators will perform CLEAR by placing 4 bands at the GEJ The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD
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