NCT03669874 Endoscopic Fundoplication With MUSE System
| NCT ID | NCT03669874 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Gastro-esophageal Reflux |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2015-09-16 |
| Primary Completion | 2021-09-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2015-09-16 with a primary completion date of 2021-09-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Pier Alberto Testoni, Professor
PRINCIPAL INVESTIGATOR
San Raffaele Scientific Institute
Frequently Asked Questions
Who can join the NCT03669874 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Gastro-esophageal Reflux. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03669874 currently recruiting?
Yes, NCT03669874 is actively recruiting participants. Contact the research team at testoni.pieralberto@hsr.it for enrollment information.
Where is the NCT03669874 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT03669874 clinical trial?
NCT03669874 is sponsored by IRCCS San Raffaele. The principal investigator is Pier Alberto Testoni, Professor at San Raffaele Scientific Institute. The trial plans to enroll 80 participants.