NCT07293611

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Levita Magnetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-23
• Primary completion: 2026-10-10
• Completion: 2026-11-30
• First posted: 2025-12-19
• Last updated: 2026-03-04

Locations

2 sites across 1 country: Chile

Regulatory

• FDA-regulated device study