Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
A Worldwide Post-Market Surveillance Registry to Assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the Treatment of GERD
This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study.
The registry evaluates the MUSE System which creates a transoral anterior fundoplication for
the treatment of GERD. The system enables the operator to staple the fundus of the stomach
to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. The
procedure is performed transorally under general anesthesia. The procedural result is
anatomically and functionally similar to standard anterior fundoplication (Dor-Thal
operation). The staples are standard, 4.8mm titanium surgical staples. Each application of
the device fires a quintuplet of staples (5) in three staggered rows. Anti-retching
medications at the time of the procedure are essential.
The study population will be primarily adults aged 18-70 years selected by the investigators
based on SAGES guidelines for fundoplication and consideration of the indications and
contraindications listed in the device Instructions for Use (IFU).
Follow-up data will be collected at 6 months, 1, 2 and 3 years post procedure.
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Observational Model: Cohort, Time Perspective: Prospective
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