Status:
COMPLETED
Clinical Evaluation of the Levita Robotic Platform
Lead Sponsor:
Levita Magnetics
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Bariatric Surgery Candidate
Cholelithiases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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)
Detailed Description
Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05353777
Start Date
May 15 2021
End Date
August 29 2022
Last Update
May 28 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinica Indisa
Santiago, Santiago Metropolitan, Chile
2
Hospital FACH
Santiago, Santiago Metropolitan, Chile
3
Hospital San Borja
Santiago, Santiago Metropolitan, Chile
4
Hospital Tisne
Santiago, Santiago Metropolitan, Chile