Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures

NCT05695989 | Completed Results

• 1 other identifier: CP008
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)

Conditions

Bariatric Surgery Candidate; Cholelithiases; Other Disease

Outcome Measures

Primary Outcomes (1)

• Adverse Events- Safety

  Adverse events related to the device

  30 days

Secondary Outcomes (2)

• Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon

  Surgery time

• Conversion Rate to Open Surgery

  Surgery time

Study Arms (1)

DRAA (Dual Robotic Arm Accessory)

EXPERIMENTAL

Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon.

Device: Dual Robotic Arm Accessory (DRAA)

Interventions

Dual Robotic Arm Accessory (DRAA) DEVICE

Dual Robotic Arm Accessory (DRAA)

DRAA (Dual Robotic Arm Accessory)

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 Prisoner or under incarceration

Sponsors & Collaborators

• Levita Magnetics: lead
• The Cleveland Clinic: collaborator

Study Sites (3)

Hospital Tisne

Santiago, Santiago Metropolitan, Chile

Location

Clinica Colonial

Santiago, Chile

Location

Hospital Fach

Santiago, 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

• Julio Jimenez, MD

  Hospital Tisne

  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: January 13, 2023
• First Posted: January 25, 2023
• Study Start: January 19, 2023
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (3)