Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

Bariatric Surgery Candidate Clinical Trial

Official title:

Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432088
• Other study ID #: LVT009
• Secondary ID: CP009
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Hernia, Hiatal
• Hiatal Hernia

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