Recruiting NCT03669874

Endoscopic Fundoplication With MUSE System

— Observational Gastro-esophageal Reflux Endoscopic Fundoplication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Endoscopic fundoplication.
Who it may be relevant to: Registry conditions: Gastro-esophageal Reflux, Endoscopic Fundoplication. Basic parameters: 18 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients

Overview

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

Interventions

Device 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

Primary outcome measures

To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Time frame: change from baseline GERD-HRQL at 6 months]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Time frame: change from baseline GERD-HRQL at 12 months]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Time frame: change from baseline GERD-HRQL at 24 months]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Time frame: change from baseline GERD-HRQL at 3 years]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Time frame: change from baseline GERD-HRQL at 4 years]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Time frame: change from baseline GERD-HRQL at 5 years]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Time frame: change from baseline GERD-HRQL at 6 years]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [Time frame: change from baseline RSI at 6 months]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [Time frame: change from baseline RSI at 12 months]
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [Time frame: change from baseline RSI at 24 months]

Secondary outcome measures (12)

To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [Time frame: change from baseline hiatal hernia size at 6 months]
To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [Time frame: change from baseline hiatal hernia size at 12 months]
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [Time frame: change from baseline Hill's grade at 6 months]
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [Time frame: change from baseline Hill's grade at 12 months]
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [Time frame: change from baseline Jobe's lenght at 6 months]
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [Time frame: change from baseline Jobe's lenght at 12 months]
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [Time frame: change from baseline esophagitis' grade at 6 months]
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [Time frame: change from baseline esophagitis' grade at 12 months]
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [Time frame: change from baseline DeMeester score at 6 months]
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [Time frame: change from baseline DeMeester score at 12 months]
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [Time frame: change from baseline AET at 6 months]
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [Time frame: change from baseline AET at 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model: Cohort

Study locations

Italy · 1 center

Pier Alberto Testoni — Milan

Publications

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 PMID 34799745
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. PMID 32187630

Identifiers

NCT: NCT03669874 · MUSE/2015

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗