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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06432088
Other study ID # LVT009
Secondary ID CP009
Status Recruiting
Phase N/A
First received
Last updated
Start date May 13, 2024
Est. completion date November 2024

Study information

Verified date May 2024
Source Levita Magnetics
Contact Vivian Soto
Phone +56958360507
Email vsoto@levita.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Chile Hospital Santiago Oriente Dr. Luis Tisné Brousse Santiago Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
Levita Magnetics

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 days
Primary Mobilization 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. 1 day
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