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

NCT07293611 | Completed FDA Device

• 1 other identifier: LVT011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Upper Gastrointestinal Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Magnetic Surgical System in laparoscopic upper gastrointestinal procedures

EXPERIMENTAL

Device: Levita Magnetic Surgical System

Interventions

Levita Magnetic Surgical System DEVICE

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.

Magnetic Surgical System in laparoscopic upper gastrointestinal procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Levita Magnetics: lead

Study Sites (2)

Clinica Colonial

Huechuraba, Santiago Metropolitan, 8580645, Chile

Location

Hospital Luis Tisne

Peñalolén, Santiago Metropolitan, 7930124, Chile

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 19, 2025
• Study Start: March 30, 2026
• Primary Completion: May 5, 2026
• Study Completion: June 12, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

CL (2)