Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

  • STATUS
    Not Recruiting
  • participants needed
    200
  • sponsor
    Medigus Ltd
Updated on 21 January 2021
fundoplication
cough
esophagitis

Summary

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.

Description

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.

Details
Condition Gastroesophageal Reflux
Treatment Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure
Clinical Study IdentifierNCT02366169
SponsorMedigus Ltd
Last Modified on21 January 2021

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