Endoscopic Fundoplication With MUSE System

Launched by IRCCS SAN RAFFAELE · Sep 11, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients suffering from gastro-esophageal reflux disease (GERD), a condition where stomach acid frequently flows back into the esophagus, causing discomfort. The treatment being evaluated is called endoscopic fundoplication using a special device called the MUSE System. This procedure aims to improve symptoms of GERD, reduce the need for medication, and enhance the overall quality of life for patients. The study will follow participants for up to six years to assess the effectiveness and safety of this treatment.

To be eligible for the trial, participants should have experienced GERD symptoms for more than six months and have evidence of GERD through medical tests. They should also be suitable candidates for the surgical procedure and able to commit to long-term follow-up visits. Throughout the study, participants will undergo various check-ups, including endoscopies and questionnaires to track their symptoms and overall health. It's important to note that individuals with certain conditions, such as a large hiatal hernia or significant previous surgeries, may not qualify for this trial.

Gender

ALL

Eligibility criteria

• 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