RecruitingNCT03669874

Endoscopic Fundoplication With MUSE System

Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients

Sponsor

IRCCS San Raffaele

Enrollment

80 participants

Start Date

Sep 16, 2015

Study Type

OBSERVATIONAL

Conditions

Gastro Esophageal Reflux Endoscopic Fundoplication

Summary

This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives: * Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of: * effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores * effect on the use and dosage of proton pump inhibitors (PPI) * feasibility and safety of the endoluminal fundoplication procedure * Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure. The study design includes the following phases: \*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI * 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI * 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI * Yearly clinical follow-up (up to 6 years): PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
Indication to surgical fundoplication
Patients available for a long-term follow-up

Exclusion Criteria8

Hiatal hernia ≥ 3 cm
Major esophageal motility disorder
Esophageal stenosis
Malignant neoplasia (except minor superficial skin neoplasm)
Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
Previous cardiac, thoracic or upper GI surgery
BMI >40
Pregnancy or breast feeding

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Interventions

DEVICEEndoscopic fundoplication

Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication. The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication.