A Study at Multiple Centers to Evaluate… | Clinical Trial

Key information

Conditions

Upper Gastrointestinal Laparoscopic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Colonial, Huechuraba, Santiago Metropolitan, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Number of Participants with Device and/or Procedure Related Adverse Events

Time frame: From enrollment to end of follow up at 30 days.

Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Average Number of Ports

Time frame: During index procedure.

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.

Sponsors and collaborators

Lead sponsor

Levita Magnetics

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Dec 19, 2025
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.