A Registry of Patients Treated with the Medigus Ultrasonic Surgical Endostapler for Gastroesophageal Reflux Disease

Overview

About this study

This registry is intended as an observational, post-marketing surveillance tool. The purpose of this registry is to collect baseline demographics and user experience of the commercially available MUSE (Medigus Ultrasonic Endostapler) system for the treatment of gastroesophageal reflux disease. The data collection aims to gather a minimum of 3 years follow-up on a large number of subjects during use of the system outside of a prescribed clinical study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Objective evidence of gastroesophageal reflux disease (GERD) that generally follows the guidelines for Laparoscopic Fundoplication published by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons)
  • Positive acid exposure test or endoscopic evidence of esophagitis
  • Inadequate symptom control
  • Patient preference for surgery over medications
  • Extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration)

Exclusion Criteria

  • Significant co-morbidity (for example, American Society of Anesthesiologists grade 3 or higher)
  • BMI >35 or <20
  • No response to proton pump inhibitors
  • Grade IV esophagitis
  • Hiatal hernia >3 cm
  • Irreducible hernia of any size
  • Gastric outlet obstruction
  • Short esophagus
  • Esophageal diverticula, strictures or varices
  • Esophageal motility disorders

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Barham Abu Dayyeh, M.D., M.P.H.

Closed for enrollment

More information

Publications

  • The initial 6-month data for MUSE™ (Medigus, Omer, Israel) endoscopic stapling device were reported (Zacherl et al. in Surg Endosc 29:220-229, 2015). The current study aims to evaluate the long-term clinical outcome of 37 patients who received endoscopic gastroesophageal reflux disease (GERD) treatment with the MUSE™ device. Read More on PubMed
  • This is a report of an IRB-approved pilot study of 13 patients who received a trans-oral anterior partial fundoplication for the treatment of GERD using an ultrasound-guided, flexible surgical stapler. All patients had a history of PPI use, objective evidence of GERD, and no significant comorbidity. Under general anesthesia, a flexible stapler was passed trans-orally into the stomach and placed two or three quintuplets of titanium staples approximately 3 cm above the gastroesophageal junction. The stapler contains an ultrasonic range finder, video camera, and illuminator. Read More on PubMed
  • Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler. Read More on PubMed

Additional contact information

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Phone: 800-664-4542 (toll-free)

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