Actively Recruiting
Endoscopic Fundoplication With MUSE System
Led by IRCCS San Raffaele · Updated on 2020-12-11
80
Participants Needed
1
Research Sites
571 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Endoscopic Fundoplication With MUSE System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
- Endoscopic or pH-impedance evidence of GERD (such as esophagitis, Barrett's esophagus, NERD, or hypersensitive esophagus)
- Indication for surgical fundoplication
- Patients must be available for long-term follow-up
You will not qualify if you...
- Hiatal hernia 3 cm or larger
- Major esophageal motility disorders
- Esophageal narrowing or stenosis
- Malignant tumors except minor superficial skin neoplasms
- Portal hypertension or bleeding disorders that contraindicate surgery, esophageal varices, stenosis, or diverticula
- Previous cardiac, thoracic, or upper gastrointestinal surgery
- Body mass index (BMI) over 40
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Pier Alberto Testoni
Milan, Italy, 20132
Actively Recruiting
Research Team
P
Pier Alberto Testoni, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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