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Endoscopic Fundoplication With MUSE System

StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 11, 2020 (before its estimated September 16, 2021 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Dec 2020); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv3
  3. Primary endpoints revised (21) Secondary endpoints: details revised at 6 of 48 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 6 of 48 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT03669874
Lead Sponsor IRCCS San Raffaele
Conditions Gastro-esophageal Reflux, Endoscopic Fundoplication
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov