Ignite Creation Date:
2024-05-06 @ 1:21 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03999502
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2019-01-07
Brief Title:
Endomina Suturing Device as a Treatment of GERD
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
A Pilot Study to Evaluate the Feasibility and the Safety of an Endoluminal-suturing Device Endoimna as a Treatment of GERD
Status:
UNKNOWN
Status Verified Date:
2021-03
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:
Gastroesophageal Reflux Disease GERD is a common problem affecting 10-20 of the population in the Western World
Surgical therapy is able to restore the EGJ barrier function against reflux of the gastric content decreases symptoms and improves the quality of life in GERD patients However there remain concerns regarding postoperative adverse events and the durability of the surgical procedure
The ability to perform endoscopic full-thickness plications with Endomina-v2 will be used to assess safety and feasibility of the procedure in reducing GERD in patients suffering with chronic GERD unsatisfied with PPIs andor complaining of persistent GERD symptoms despite PPI use
Surgical therapy is able to restore the EGJ barrier function against reflux of the gastric content decreases symptoms and improves the quality of life in GERD patients However there remain concerns regarding postoperative adverse events and the durability of the surgical procedure
The ability to perform endoscopic full-thickness plications with Endomina-v2 will be used to assess safety and feasibility of the procedure in reducing GERD in patients suffering with chronic GERD unsatisfied with PPIs andor complaining of persistent GERD symptoms despite PPI use
Detailed Description:
Gastroesophageal Reflux Disease GERD is a common problem affecting 10-20 of the population in the Western World Approximately 250 million subjects worldwide and 30 million subjects in the US suffer from GERD Among the 12 million Americans who suffer from daily heart-burn the main symptom of GERD almost 5 million do not respond completely to medications and many more do not want or cannot take medications due to side-effects 1 The goals of treatment in GERD are to relieve symptoms heal esophagitis if present prevent recurrence of symptoms and esophagitis and prevent complications Medical acid-suppressive therapy with proton pump inhibitors PPIs heals esophagitis relieves symptoms and improves quality of life However acid suppressive therapy does not correct the underlying pathophysiology of dysfunction of the lower esophageal sphincter and hence symptoms of reflux due to weakly acidic or non-acid reflux persist in the majority of subjects who present with symptoms persisting on PPIs regurgitations 2
Abnormalities in the structure and function of the esophago-gastric junction EGJ such as a permanently open EGJ a hiatal hernia a hypotensive lower esophageal sphincter LES and transient LES relaxations t-LESR are the main pathophysiologic mechanisms leading to GERD 3
Surgical therapy is able to restore the EGJ barrier function against reflux of the gastric content decreases symptoms and improves the quality of life in GERD patients 45 However there remain concerns regarding postoperative adverse events and the durability of the surgical procedure 67 The results reported from operations performed in community hospital lower volume centers have been different than those achieved in centers of excellence It has been reported that between 23 and 62 of patients who have undergone laparoscopic Nissen fundoplication use acid suppression medications at long-term follow-up Due to these issues patient and physician acceptance of surgical procedures remains low and is mainly limited to patients with severe GERD or those non-responsive to medications For these reasons less invasive endoscopic techniques to treat GERD have been developed during the last 2 decades which may be categorized into 3 groups 1 sewingplication at the cardia and EGJ 2 radiofrequency RF thermal therapy to the LES and 3 injectionimplantation of biopolymers at the EGJ Minimally invasive endoluminal procedures for GERD are designed to provide long-lasting symptom relief and abolish or lessen medication dependency Most endoluminal modalities that were introduced into clinical practice have failed due to lack of long-term efficacy complications or interruption of commercialization due to financial difficulties of the companies that developed the techniques 89 Endoscopic sewingplication techniques comprised mucosal plications Endocinch that were not clinically useful because the plications were not durable and full-thickness serosa-to-serosa plications allowing prolonged durability NDO Plicator device and Esophyx device The data from the RCTs with Plicator device were encouraging and the finding of better results with multiple plications without an increase in adverse events supported that this device could have clinical utility However the company ceased operations in 2008 and the device is no longer clinically available 10 Transoral incisionless fundoplication TIF using Esophyx showed promising results in open studies 11 However long-term follow-up revealed that a majority of patients required either ongoing PPI use or were referred for LNF owing to persistent symptoms 12
Endomina-v2 Endo Tools Therapeutics SA Rue Auguste Piccard 48 6041 GOSSELIES Belgium is a CE marked device that can be attached to an endoscope inside the body and allows manipulation of angulated tools during a peroral intervention It offers the possibility to perform transoral surgical full thickness sutures and transoral endoscopic gastroplasty has shown to be safe and effective at mid-term follow-up in obese patients 13 The ability to perform endoscopic full-thickness plications with Endomina-v2 will be used to assess safety and feasibility of the procedure in reducing GERD in patients suffering with chronic GERD unsatisfied with PPIs andor complaining of persistent GERD symptoms despite PPI use
Abnormalities in the structure and function of the esophago-gastric junction EGJ such as a permanently open EGJ a hiatal hernia a hypotensive lower esophageal sphincter LES and transient LES relaxations t-LESR are the main pathophysiologic mechanisms leading to GERD 3
Surgical therapy is able to restore the EGJ barrier function against reflux of the gastric content decreases symptoms and improves the quality of life in GERD patients 45 However there remain concerns regarding postoperative adverse events and the durability of the surgical procedure 67 The results reported from operations performed in community hospital lower volume centers have been different than those achieved in centers of excellence It has been reported that between 23 and 62 of patients who have undergone laparoscopic Nissen fundoplication use acid suppression medications at long-term follow-up Due to these issues patient and physician acceptance of surgical procedures remains low and is mainly limited to patients with severe GERD or those non-responsive to medications For these reasons less invasive endoscopic techniques to treat GERD have been developed during the last 2 decades which may be categorized into 3 groups 1 sewingplication at the cardia and EGJ 2 radiofrequency RF thermal therapy to the LES and 3 injectionimplantation of biopolymers at the EGJ Minimally invasive endoluminal procedures for GERD are designed to provide long-lasting symptom relief and abolish or lessen medication dependency Most endoluminal modalities that were introduced into clinical practice have failed due to lack of long-term efficacy complications or interruption of commercialization due to financial difficulties of the companies that developed the techniques 89 Endoscopic sewingplication techniques comprised mucosal plications Endocinch that were not clinically useful because the plications were not durable and full-thickness serosa-to-serosa plications allowing prolonged durability NDO Plicator device and Esophyx device The data from the RCTs with Plicator device were encouraging and the finding of better results with multiple plications without an increase in adverse events supported that this device could have clinical utility However the company ceased operations in 2008 and the device is no longer clinically available 10 Transoral incisionless fundoplication TIF using Esophyx showed promising results in open studies 11 However long-term follow-up revealed that a majority of patients required either ongoing PPI use or were referred for LNF owing to persistent symptoms 12
Endomina-v2 Endo Tools Therapeutics SA Rue Auguste Piccard 48 6041 GOSSELIES Belgium is a CE marked device that can be attached to an endoscope inside the body and allows manipulation of angulated tools during a peroral intervention It offers the possibility to perform transoral surgical full thickness sutures and transoral endoscopic gastroplasty has shown to be safe and effective at mid-term follow-up in obese patients 13 The ability to perform endoscopic full-thickness plications with Endomina-v2 will be used to assess safety and feasibility of the procedure in reducing GERD in patients suffering with chronic GERD unsatisfied with PPIs andor complaining of persistent GERD symptoms despite PPI use
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