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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05353777
Other study ID # CP007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date August 29, 2022

Study information

Verified date May 2024
Source Levita Magnetics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Description:

Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic procedures.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date August 29, 2022
Est. primary completion date August 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - • 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 Exclusion Criteria: - • 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

Study Design


Intervention

Device:
Levita Robotic Platform
Levita Robotic Platform

Locations

Country Name City State
Chile Clinica Indisa Santiago Metropolitana
Chile Hospital FACH Santiago Metropolitana
Chile Hospital San Borja Santiago Metropolitana
Chile Hospital Tisne Santiago Metropolitana

Sponsors (2)

Lead Sponsor Collaborator
Levita Magnetics The Cleveland Clinic

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events- Safety Adverse events related to the device 30 days
Secondary Rate that the Levita Robotic Platform is able to engage, move, and decouple with the Magnetic Surgical System as controlled by the surgeon Ratio of successful attempts vs unsuccessful attempts Surgery time
Secondary Conversion rate to open surgery Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization Surgery time
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