Endoscopic Fundoplication With MUSE System

San Donato Group (GSD)

Status: Enrolling

Conditions: Gastro-esophageal Reflux; Endoscopic Fundoplication

Treatments: Device: Endoscopic fundoplication

Study type: Observational

Funder types: Other

Identifiers

NCT03669874

MUSE/2015

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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