N/A
N=48
Clinical Evaluation of the Levita Robotic Platform
Bariatric Surgery Candidate · Cholelithiases · Other Disease
Bottom Line
View on ClinicalTrials.gov: NCT05353777 ↗Enrolled (actual)
48
Serious AEs
2.2%
Results posted
May 2025
Primary outcome: Primary: Adverse Events Related to the Device — 3 Adverse events related to device
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Levita Robotic Platform (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Levita Magnetics
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events Related to the Device |
3 | — |
| SECONDARY Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon |
46 | — |
| SECONDARY Conversion Rate to Open Surgery |
— | — |
Summary
The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)
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
Data sourced from ClinicalTrials.gov (NCT05353777). 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.