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Clinical Evaluation of the Levita Robotic Platform

Primary Purpose

Bariatric Surgery Candidate, Cholelithiases, Other Disease

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Levita Robotic Platform
Sponsored by
Levita Magnetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica IndisaRecruiting
  • Hospital FACHRecruiting
  • Hospital San BorjaRecruiting
  • Hospital TisneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levita Robotic Platform

Arm Description

Outcomes

Primary Outcome Measures

Adverse events- Safety
Adverse events related to the device

Secondary Outcome Measures

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
Conversion rate to open surgery
Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization

Full Information

First Posted
April 12, 2022
Last Updated
April 25, 2022
Sponsor
Levita Magnetics
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05353777
Brief Title
Clinical Evaluation of the Levita Robotic Platform
Official Title
Clinical Evaluation of the Levita Robotic Platform
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Levita Magnetics
Collaborators
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Cholelithiases, Other Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levita Robotic Platform
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Levita Robotic Platform
Intervention Description
Levita Robotic Platform
Primary Outcome Measure Information:
Title
Adverse events- Safety
Description
Adverse events related to the device
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate that the Levita Robotic Platform is able to engage, move, and decouple with the Magnetic Surgical System as controlled by the surgeon
Description
Ratio of successful attempts vs unsuccessful attempts
Time Frame
Surgery time
Title
Conversion rate to open surgery
Description
Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization
Time Frame
Surgery time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Soto
Phone
+56958360507
Email
CP007@levita.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio Robles, MD
Organizational Affiliation
Hospital FACH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Indisa
City
Santiago
State/Province
Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Robles, MD
Facility Name
Hospital FACH
City
Santiago
State/Province
Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Robles, MD
Facility Name
Hospital San Borja
City
Santiago
State/Province
Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Fulla, MD
Facility Name
Hospital Tisne
City
Santiago
State/Province
Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Jimenez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Evaluation of the Levita Robotic Platform

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