Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

Levita Magnetics

Status: Completed

Conditions: Bariatric Surgery Candidate

Treatments: Device: Levita Magnetic Surgical System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03508674

CP003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures

Full description

Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 18 years of age
• scheduled to undergo bariatric procedure

Exclusion criteria

• Am Soc Anesthesiology score of III or IV
• significant comorbidities
• subjects contraindicated for use of magnetic system
• clinical history of impaired coagulation
• hepatic abnormality or anatomical abnormality

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intervention

Experimental group

Description:

Levita Magnetic Surgical System

Treatment:

Device: Levita Magnetic Surgical System