Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03669874
Status:
RECRUITING
Last Update Posted:
2020-12-11
First Post:
2018-08-30
Brief Title:
Endoscopic Fundoplication With MUSE System
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
Status:
RECRUITING
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None