A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
NCT ID: NCT07293611
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-10
2026-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Magnetic Surgical System in laparoscopic upper gastrointestinal procedures
Levita Magnetic Surgical System
The Magnetic Surgical System (MSS), which was cleared for market in the U.S. most recently per 510(k) K252435 and is commercially available in Chile, is composed of two hand-held instruments: a Magnetic Grasper and an external Magnetic Controller.
The Magnetic Grasper is comprised of two main components: a detachable Grasper Tip and a Shaft. The detachable Grasper Tip provided with the Magnetic Grasper is 6.5cm in length. An optional 12.5cm length detachable Grasper Tip may be used as a replacement for the 6.5cm Grasper Tip and can be used with the Shaft interchangeably. The Magnetic Controller is a single unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip.
In this study the 6.5 Grasper Tip will be used.
Interventions
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Levita Magnetic Surgical System
The Magnetic Surgical System (MSS), which was cleared for market in the U.S. most recently per 510(k) K252435 and is commercially available in Chile, is composed of two hand-held instruments: a Magnetic Grasper and an external Magnetic Controller.
The Magnetic Grasper is comprised of two main components: a detachable Grasper Tip and a Shaft. The detachable Grasper Tip provided with the Magnetic Grasper is 6.5cm in length. An optional 12.5cm length detachable Grasper Tip may be used as a replacement for the 6.5cm Grasper Tip and can be used with the Shaft interchangeably. The Magnetic Controller is a single unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip.
In this study the 6.5 Grasper Tip will be used.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo laparoscopic 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 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 who have 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
18 Years
ALL
No
Sponsors
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Levita Magnetics
INDUSTRY
Responsible Party
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Locations
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Clinica Colonial
Huechuraba, Santiago Metropolitan, Chile
Hospital Luis Tisne
Peñalolén, Santiago Metropolitan, Chile
Countries
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Facility Contacts
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Principal Investigator
Role: primary
Principal Investigator
Role: primary
Other Identifiers
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LVT011
Identifier Type: -
Identifier Source: org_study_id