Bariatric Surgery Candidate, Cholelithiases, Other Disease
Conditions
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 procedures.
Interventions
DEVICELevita Robotic Platform
Levita Robotic Platform
Sponsors
The Cleveland Clinic
Levita Magnetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Related to the Device | 30 days | Total number of adverse events related to the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon | Interoperatively | Number of successfully performed surgeries without the need of additional tools. |
| Conversion Rate to Open Surgery | Interoperatively | Conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization. |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Levita Robotic Platform Levita Robotic Platform: Levita Robotic Platform | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | Levita Robotic Platform |
|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 13.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Chile | 46 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 15 / 46 |
| serious Total, serious adverse events | 1 / 46 |
Outcome results
Primary
Adverse Events Related to the Device
Total number of adverse events related to the device.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levita Robotic Platform | Adverse Events Related to the Device | 3 Adverse events related to device |
Secondary
Conversion Rate to Open Surgery
Conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization.
Time frame: Interoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levita Robotic Platform | Conversion Rate to Open Surgery | 0 Converted procedures |
Secondary
Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon
Number of successfully performed surgeries without the need of additional tools.
Time frame: Interoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levita Robotic Platform | Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon | 46 Successfully performed surgeries |