Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-31 @ 10:09 AM
Study NCT ID:
NCT03999502
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endomina Suturing Device as a Treatment of GERD.
Sponsor:
Erasme University Hospital
Organization:
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, and/or 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, and/or 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 (4,5). However, there remain concerns regarding postoperative adverse events and the durability of the surgical procedure (6,7). 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) sewing/plication at the cardia and EGJ, (2) radiofrequency (RF) thermal therapy to the LES, and (3) injection/implantation 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 (8,9). Endoscopic sewing/plication 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, and/or 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 (4,5). However, there remain concerns regarding postoperative adverse events and the durability of the surgical procedure (6,7). 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) sewing/plication at the cardia and EGJ, (2) radiofrequency (RF) thermal therapy to the LES, and (3) injection/implantation 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 (8,9). Endoscopic sewing/plication 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, and/or complaining of persistent GERD symptoms despite PPI use.
Study Oversight
Has Oversight DMC:
True
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?: