Bariatric Surgery Candidate, Cholelithiases, Other Disease
Conditions
Brief 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)
Detailed description
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
Interventions
DEVICEDual Robotic Arm Accessory (DRAA)
Dual Robotic Arm Accessory (DRAA)
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 Prisoner or under incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events- Safety | 30 days | Adverse events related to the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Surgery time | Ratio of successful attempts vs unsuccessful attempts |
| Conversion Rate to Open Surgery | Surgery time | Ratio of 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 |
|---|---|
| DRAA (Dual Robotic Arm Accessory) Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | DRAA (Dual Robotic Arm Accessory) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Chile | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 12 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Adverse Events- Safety
Adverse events related to the device
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRAA (Dual Robotic Arm Accessory) | Adverse Events- Safety | 0 Device related adverse events |
Secondary
Conversion Rate to Open Surgery
Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization
Time frame: Surgery time
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRAA (Dual Robotic Arm Accessory) | Conversion Rate to Open Surgery | 0 Converted procedures |
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
Ratio of successful attempts vs unsuccessful attempts
Time frame: Surgery time
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRAA (Dual Robotic Arm Accessory) | 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 Number Surgeries completed successfully |