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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 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Levita Magnetics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2026-05-05
Completion
2026-06-05
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07293611 on ClinicalTrials.gov