Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surg… (NCT05695989) | Clinical Trial Compass
CompletedNot Applicable
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
Chile22 participantsStarted 2023-01-19
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.