NCT02049983

Brief Summary

The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
9.6 years until next milestone

Results Posted

Study results publicly available

September 25, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

January 28, 2014

Results QC Date

January 18, 2018

Last Update Submit

September 19, 2024

Conditions

Benign Gallbladder Disease

Outcome Measures

Primary Outcomes (2)

  • Safety Assessment of AEs

    Absence of any damage or side effect to the patient directly produced by the device during the surgery

    During surgery

  • Feasibility of Mobilization

    Ability to adequately mobilize the organ during the surgery

    Intra-operative

Study Arms (1)

Use of Levita Magnetics Grasper

EXPERIMENTAL
Device: Use of Levita Magnetics Grasper

Interventions

Use of Levita Magnetics GrasperDEVICE
Use of Levita Magnetics Grasper

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient is between 18 and 60 years of age
  • Undergoing elective cholecystectomy due to:
  • Cholelithiasis (Gallbladder stones \< 2.5cm in longer measurement (length or width))
  • Gallbladder polyps as assessed by ultrasound
  • Absence of non-correctable coagulopathy (INR \< 1.4 or, platelet count of \< 50,000/mcl)
  • Patient has a body mass index (BMI) ≤ 35 kg/m2 and over 20
  • Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure

You may not qualify if:

  • Emergency presentation with acute gallbladder disease
  • Pancreatitis
  • Jaundice
  • Scleroatrophic gallbladder as shown by ultrasound
  • Biliary tract stones diagnosed before or during surgery
  • Acute cholecystitis
  • Gallbladder Empyema
  • Ongoing peritoneal dialysis
  • Previous abdominal surgery or laparotomy (presence of any previous upper umbilical incision)
  • Presence of umbilical hernia or previous umbilical hernia
  • American Society of Anesthesiologists (ASA) score of III or IV
  • Patient is undergoing treatment for chronic pain of any origin
  • Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
  • Patients with signs of gallbladder perforation diagnosed by ultrasound
  • Suspicion of biliary cancer
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Luis Tisne

Santiago, Santiago Metropolitan, 7500000, Chile

Location

Hospital Padre Hurtado

Santiago, Santiago Metropolitan, 7500000, Chile

Location

Hospital Salvador

Santiago, Santiago Metropolitan, 7500000, Chile

Location

Related Publications (1)

  • Rivas H, Robles I, Riquelme F, Vivanco M, Jimenez J, Marinkovic B, Uribe M. Magnetic Surgery: Results From First Prospective Clinical Trial in 50 Patients. Ann Surg. 2018 Jan;267(1):88-93. doi: 10.1097/SLA.0000000000002045.

    PMID: 27759614BACKGROUND

Results Point of Contact

Title
Alberto Rodriguez-Navarro, MD
Organization
Levita Magnetics International Corp
info@levita.com
6506557625

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 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 25, 2024

Results First Posted

September 25, 2024

Record last verified: 2024-09

Locations

CL(3)