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NCT05695989
Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
Conditions: Bariatric Surgery Candidate, Cholelithiases, Other Disease
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: Levita Magnetics
Location: Chile
Summary
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
Eligibility Criteria
Inclusion Criteria:• Subject is at least 18 years of ageSubject is scheduled to undergo elective laparoscopic procedureSubject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required proceduresExclusion Criteria:• Subjects with pacemakers, defibrillators, or other electromedical implantsSubjects with ferromagnetic implantsSubjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)Subjects with a clinical history of impaired coagulation confirmed by abnormal blood testsSubject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device useSubject is pregnant or wishes to become pregnant during the length of study participationSubject is not likely to comply with the follow-up evaluation scheduleSubject is participating in a clinical trial of another investigational drug or device Prisoner or under incarceration
Source: ClinicalTrials.gov (NCT05695989). StuddyBuddy aggregates publicly available trial information.