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Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

NCT02366169 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2016-04-04

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DEVICE

Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure

The procedure is performed transorally under general anesthesia. The physicians staples the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. 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.

Sponsors & Collaborators

  • Medigus Ltd

    lead INDUSTRY

Principal Investigators

  • Ralf Kiesslich, MD · Director Klinik für Innere Medizin II; Dr. Horst Schmidt Klinik

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2019-12-31

Countries

  • United States
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366169 on ClinicalTrials.gov