N/A
Completed N=22
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
Bariatric Surgery Candidate · Cholelithiases · Other Disease
Source: ClinicalTrials.gov NCT05695989 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Adverse Events- Safety — 0 Device related adverse events
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events- Safety |
— | — |
| SECONDARY Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon |
20 | — |
| SECONDARY Conversion Rate to Open Surgery |
— | — |
Eligibility Criteria
Inclusion Criteria
- • Subject is at least 18 years of age
- Subject is scheduled to undergo elective laparoscopic procedure
- Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures
Exclusion Criteria
- • Subjects with pacemakers, defibrillators, or other electromedical implants
- Subjects with ferromagnetic implants
- Subjects 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 tests
- Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
- Subject is pregnant or wishes to become pregnant during the length of study participation
- Subject is not likely to comply with the follow-up evaluation schedule
- Subject is participating in a clinical trial of another investigational drug or device Prisoner or under incarceration
Data sourced from ClinicalTrials.gov (NCT05695989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.