Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2015-09-16
2026-09-30
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Endoscopic fundoplication
Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication.
The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Pier Alberto Testoni
Professor
Principal Investigators
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Pier Alberto Testoni, Professor
Role: PRINCIPAL_INVESTIGATOR
San Raffaele Scientific Institute
Locations
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Pier Alberto Testoni
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Pier Alberto Testoni, MD
Role: primary
References
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Testoni SGG, Cilona MB, Mazzoleni G, Fanti L, Ribichini E, Cavestro GM, Esposito D, Viale E, Notaristefano C, Zuppardo RA, Azzolini F, Passaretti S, Testoni PA. Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years. Surg Endosc. 2022 Jul;36(7):5023-5031. doi: 10.1007/s00464-021-08860-w. Epub 2021 Nov 19.
Testoni PA, Testoni S, Mazzoleni G, Pantaleo G, Cilona MB, Distefano G, Fanti L, Antonelli M, Passaretti S. Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes. Endoscopy. 2020 Jun;52(6):469-473. doi: 10.1055/a-1124-3187. Epub 2020 Mar 18.
Other Identifiers
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MUSE/2015
Identifier Type: -
Identifier Source: org_study_id