Endomina Suturing Device as a Treatment of GERD.

NCT03999502 | Unknown DMC

• 1 other identifier: P2018/260
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD

Keywords

Endoscopy; Mini invasive

Outcome Measures

Primary Outcomes (2)

• number of sutures at endoscopy (feasibility)

  persistence of sutures at endoscopy

  12 months follow-up

• Incidence of all Adverse Device Effects

  Safety will be characterized by the incidence of all Adverse Device Effects

  12 months follow-up

Secondary Outcomes (7)

• Assessment of Reflux (1)

  6 month follow-up

• Assessment of Reflux (2)

  6 month follow-up

• Evaluation of Esogastric junction

  6 month follow-up

• Gastro-esophageal reflux disease health-related quality of life score (GERD-HRQL score)

  Baseline 3, 6 and 12 month follow-up

• Reflux Symptom Index Score

  Baseline 3, 6 and 12 month follow-up

Study Arms (1)

Intervention

EXPERIMENTAL

The procedure will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over a guidewire and then fixed to the endoscope. The procedure will include at least one suture of the gastric cardia to tighten it. Patients will be kept overnight after the procedure.

Device: Endomina

Interventions

Endomina DEVICE

The procedure will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over a guidewire and then fixed to the endoscope. The procedure will include at least one suture of the gastric cardia to tighten it. Patients will be kept overnight after the procedure.

Intervention

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject is 21 - 70 years of age at the time of informed consent 2. Subject has documented symptoms of GERD (heartburn and/or regurgitation) for longer than 12 months, which respond at least partially to proton pump inhibitors (PPIs) 3. Subject is under continuous PPI therapy for at least 6 months 4. Subject has a diagnosis of GERD 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) performed after at least 7 days off of PPIs
• Positive symptom association between GERD symptoms and reflux episodes (symptom association probability ≥ 95%) demonstrated at pH-impedance monitoring)

You may not qualify if:

• Subject underwent previous surgery involving the gastroesophageal junction, such as a Nissen fundoplication
• Subject underwent previous endoscopic intervention for the treatment of GERD and/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 of investigator precludes an anti-reflux procedure
• Subject has history of or known esophageal stricture or significant esophageal anatomic 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 the last 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 2 years

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Vincent huberty, MD

CONTACT

003225553715; vincent.huberty@erasme.ulb.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: June 26, 2019
• Study Start: May 15, 2018
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2022
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)