A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.

Prospective, Multicenter, Single-arm, Open-label Study to Assess the Safety and Feasibility of the Levita Magnetic Surgical System for Reduced Port in Upper Gastrointestinal Laparoscopic Procedures

A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.

Study Overview

• Status: Active, not recruiting
• Conditions: Upper Gastrointestinal Laparoscopic Surgery
• Intervention / Treatment: Device: Levita Magnetic Surgical System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago Metropolitan
    • Huechuraba, Santiago Metropolitan, Chile, 8580645
      • Clinica Colonial
    • Peñalolén, Santiago Metropolitan, Chile, 7930124
      • Hospital Luis Tisne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• BMI range of 20 to 60kg/m2
• 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 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Magnetic Surgical System in laparoscopic upper gastrointestinal procedures

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Device and/or Procedure Related Adverse Events	Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.	From enrollment to end of follow up at 30 days.
Average Number of Ports	Ability to adequately retract the stomach, omentum, and small bowel to achieve effective exposure of the target tissue. Adequate retraction will be deemed to be achieved if an additional port that is typically used for retraction and exposure of target tissues can be eliminated.	During index procedure.

Collaborators and Investigators

• Sponsor: Levita Magnetics

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Actual): May 5, 2026
• Study Completion (Estimated): June 5, 2026

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LVT011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes