Clinical Evaluation of the Levita Robotic Platform

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2022-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

NCT03508674

Bariatric Surgery Candidate

COMPLETED NA

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

NCT05695989

Bariatric Surgery Candidate Cholelithiases Other Disease

COMPLETED NA

A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.

NCT07293611

Upper Gastrointestinal Laparoscopic Surgery

NOT_YET_RECRUITING NA

Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

NCT06432088

Bariatric Surgery Candidate Hiatal Hernia

COMPLETED NA

Study on the Safety and Efficacy of Domestic Single-Port Robot-Assisted Metabolic Bariatric Surgery.

NCT07335731

Obesity Robot Surgery

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bariatric Surgery Candidate Cholelithiases Other Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Levita Robotic Platform

Group Type EXPERIMENTAL

Levita Robotic Platform

Intervention Type DEVICE

Levita Robotic Platform

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levita Robotic Platform

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No