Endomina Suturing Device as a Treatment of GERD.

Phase

N/A

Condition

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT03999502

P2018/260

Ages 21-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

1. Subject is 21 - 70 years of age at the time of informed consent 2. Subject hasdocumented symptoms of GERD (heartburn and/or regurgitation) for longer than 12months, which respond at least partially to proton pump inhibitors (PPIs) 3. Subjectis under continuous PPI therapy for at least 6 months 4. Subject has a diagnosis ofGERD based on at least 2 of the following criteria:

Past demonstration of reflux esophagitis grade A, B or C (LA classification)
Abnormal esophageal acid exposure during esophageal pH-impedance monitoring (defined as distal esophageal pH < 4 for > 4 % of the monitoring time) performedafter at least 7 days off of PPIs
Positive symptom association between GERD symptoms and reflux episodes (symptomassociation probability ≥ 95%) demonstrated at pH-impedance monitoring)

Exclusion

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria cannot be enrolled in thestudy:

Subject underwent previous surgery involving the gastroesophageal junction, suchas a Nissen fundoplication
Subject underwent previous endoscopic intervention for the treatment of GERDand/or Barrett's esophagus
Subject has a hiatal hernia larger than 3 cm as determined by endoscopy
Subject has history of gastroparesis
Subject has any non-GERD esophageal motility disorders that in the opinion ofinvestigator precludes an anti-reflux procedure
Subject has history of or known esophageal stricture or significant esophagealanatomic abnormalities (obstructive lesions, etc.)
Subject has Barrett's epithelium or any grade of dysplasia
Subject has documented history of esophagitis Grade D (LA Classification)
Subject has a history of suspected or confirmed esophageal or gastric cancer
Subject has esophageal or gastric varices
Subject has symptoms of dysphagia more than once per week every week within thelast 3 months
Subject is unable to tolerate withdrawal from PPI medications
Subject has a body mass index (BMI) > 35 kg/m2
Subject has any significant multisystem diseases
Subject has an autoimmune or a connective tissue disorder (scleroderma,dematomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST),Sjogren's Syndrome, Sharp's Syndrome, etc.) requiring therapy in the preceding 2years
Subject has Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c > 9.5 in the previous 6 months or at screening/baseline
Subject has had a significant cerebrovascular event within the last 6 months
Female subject of child-bearing potential and is pregnant or nursing, or intendsto become pregnant during the trial period, who is not using a reliable form ofbirth control
Subject is currently enrolled in other potentially confounding research
Subject has an active infection as determined by the investigator
Subject has a history of any malignancy in the last 2 years
Subject has a life expectancy less than 3 years
Subject has a diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.)
Subject has any condition that, at the discretion of the investigator or sponsor,would interfere with accurate interpretation of the study endpoints or precludeparticipation in the trial
Subject has a diagnosis of eosinophilic esophagitis

Study Design

May 15, 2018

May 12, 2022

Study 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.

Connect with a study center

Gastroenterology Department Erasme Hospital
Brussels, 1070
Belgium
Active - Recruiting

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