Endoscopic Fundoplication With MUSE System

Last updated: December 10, 2020
Sponsor: IRCCS San Raffaele
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn (Pediatric)

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT03669874
MUSE/2015
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

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

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, esophagealvarices, stenosis or diverticula
  • Previous cardiac, thoracic or upper GI surgery
  • BMI >40
  • Pregnancy or breast feeding

Study Design

Total Participants: 80
Study Start date:
September 16, 2015
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Pier Alberto Testoni

    Milan, 20132
    Italy

    Active - Recruiting

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