Bariatric Surgery Candidate, Hiatal Hernia
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Detailed description
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.
Interventions
DEVICEExtended Magnetic Grasper Device
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Sponsors
Levita Magnetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age. * Scheduled to undergo elective bariatric and/or hiatal hernia procedures. * Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures.
Exclusion criteria
* Individuals with pacemakers, defibrillators, or other electromedical implants. * Individuals with ferromagnetic implants. * American Society of Anesthesiologists (ASA) score of III or IV. * Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure). * Clinical history of impaired coagulation confirmed by abnormal blood tests. * Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.). * Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use. * Pregnant or wishes to become pregnant during the length of study participation. * Individual is not likely to comply with the follow-up evaluation schedule. * Participating in a clinical trial of another investigational drug or device. * Prisoner or under incarceration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device Related Adverse Events | 30 days | All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity. |
| Mobilization Requiring Additional Retractors | 1 day | Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure. |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extended Magnetic Grasper Device Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Extended Magnetic Grasper Device: The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Extended Magnetic Grasper Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| BMI | 39.09 kg/m² STANDARD_DEVIATION 5.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Chile | 30 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 14 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Mobilization Requiring Additional Retractors
Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Magnetic Grasper Device | Mobilization Requiring Additional Retractors | 0 Procedures w/ additional retractors |
Primary
Number of Device Related Adverse Events
All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Magnetic Grasper Device | Number of Device Related Adverse Events | 0 Device related adverse events |