Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

Medigus

Status: Unknown

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Device: Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure

Study type: Observational

Funder types: Industry

Identifiers

NCT02366169

14-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Generally follow the guidelines for Laparoscopic Fundoplication published by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Objective evidence of GERD

• Positive acid exposure test or endoscopic evidence of esophagitis AND
• Inadequate symptom control or
• Patient preference from surgery over medications or
• 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