Clinical Evaluation of the Levita Robotic Platform

NCT05353777 | Completed Results

• 1 other identifier: CP007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)

Conditions

Bariatric Surgery Candidate; Cholelithiases; Other Disease

Outcome Measures

Primary Outcomes (1)

• Adverse Events Related to the Device

  Total number of adverse events related to the device.

  30 days

Secondary Outcomes (2)

• Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon

  Interoperatively

• Conversion Rate to Open Surgery

  Interoperatively

Study Arms (1)

Levita Robotic Platform

EXPERIMENTAL

Device: Levita Robotic Platform

Interventions

Levita Robotic Platform DEVICE

Levita Robotic Platform

Levita Robotic Platform

Eligibility Criteria

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

You may qualify if:

• Subject is at least 18 years of age
• Subject is scheduled to undergo elective laparoscopic procedure
• Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

You may not qualify if:

• Subjects with pacemakers, defibrillators, or other electromedical implants
• Subjects with ferromagnetic implants
• Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
• Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
• Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
• Subject is pregnant or wishes to become pregnant during the length of study participation
• Subject is not likely to comply with the follow-up evaluation schedule
• Subject is participating in a clinical trial of another investigational drug or device

Sponsors & Collaborators

• Levita Magnetics: lead
• The Cleveland Clinic: collaborator

Study Sites (4)

Clinica Indisa

Santiago, Santiago Metropolitan, Chile

Location

Hospital FACH

Santiago, Santiago Metropolitan, Chile

Location

Hospital San Borja

Santiago, Santiago Metropolitan, Chile

Location

Hospital Tisne

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Cholelithiasis; Disease

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vivian Soto
• Organization: Levita Magnetics

VSoto@Levita.com

+56958360507

Study Officials

• Ignacio Robles, MD

  Hospital FACH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 29, 2022
• Study Start: May 15, 2021
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (4)