Benign Gallbladder DiseaseNCT02049983

Levita Magnetic Grasper Device Safety and Performance Study

A study testing Use of Levita Magnetics Grasper in people with Benign Gallbladder Disease, run by Levita Magnetics at 3 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Benign Gallbladder Disease
What is being tested?: Use of Levita Magnetics Grasper
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesChile
Study dates: Jan 2014to Mar 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

Emergency presentation with acute gallbladder disease
Pancreatitis
Jaundice
Scleroatrophic gallbladder as shown by ultrasound
Biliary tract stones diagnosed before or during surgery
Acute cholecystitis

Show all 33Show fewer

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
Patients with severe peritonitis
Contraindications to pneumoperitoneum
Known allergy to paracetamol or NSAIDs
Patients with metallic implants (such as pacemakers, prosthesis, etc)
Previously diagnosed or suspected of having a history of choledocholithiasis based on any alterations in plasma hepatic enzymes
Has a biliary tract > 7mm in size as determined by ultrasound
Has a gallbladder wall thickness that is > 5mm
Diabetic Blood coagulation issues
Has signs of hepatic endocrinology (i.e: cirrhosis, liver failure, increase in liver enzymes, etc.)
History of endoscopic papillotomy (i.e: Preoperative indication of endoscopic retrograde cholangiopancreatography (ERCP)
Patient is pregnant or wishes to become pregnant during the length of study participation or lactation
Patient is not likely to comply with the follow-up evaluation schedule
Patient is participating in a clinical trial of another investigational drug or device
Patient is mentally incompetent or a prisoner
Known or suspected drug or alcohol abuse
Patient has systemic infection or evidence of any surgical site infection (superficial or organ space)
Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000), including prior or pending treatment for HIV or Hep. C
Patient intra-operatively needs an additional surgery while undergoing elective cholecystectomy

Trial locations and contacts

3 sites in 1 country.

Chile3 sites

Hospital Luis Tisne
Santiago, Santiago Metropolitan, 7500000
Hospital Padre Hurtado
Santiago, Santiago Metropolitan, 7500000
Hospital Salvador
Santiago, Santiago Metropolitan, 7500000

Other trials in Chile

About this study

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

Conditions: Benign Gallbladder Disease
Being tested: Use of Levita Magnetics Grasper

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Use of Levita Magnetics GrasperDevice

Study groups in NCT02049983
Study group	Role	What they receive
Use of Levita Magnetics Grasper	Experimental	Not described Receives: Device: Use of Levita Magnetics Grasper

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Assessment of AEs
Absence of any damage or side effect to the patient directly produced by the device during the surgery
Measured: During surgery
Feasibility of Mobilization
Ability to adequately mobilize the organ during the surgery
Measured: Intra-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Mar 2015

First posted30 Jan 2014 (estimated)
Study startJan 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Benign Gallbladder DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02049983
Sponsor's protocol ID: LEV-TP-0010
Other IDs: Grant 13IEAT-20911
Status last verified: Sep 2024
First submitted: 28 Jan 2014
Last updated: 25 Sep 2024
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 27759614

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Benign Gallbladder Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Levita Magnetic Grasper Device Safety and Performance Study
ClinicalTrials.gov ID: NCT02049983
Acronym / sponsor ID: LEV-TP-0010
Conditions: Benign Gallbladder Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Levita MagneticsIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 30 Jan 2014 (estimated)
Results: Posted 25 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Use of Levita Magnetics Grasper	Experimental	Device: Use of Levita Magnetics Grasper

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Patient is between 18 and 60 years of age

Key exclusion criteria (33 listed)

Emergency presentation with acute gallbladder disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Use of Levita Magnetics Grasper	Device	Use of Levita Magnetics Grasper

Primary outcome

Safety Assessment of AEs
Time frame: During surgery
Absence of any damage or side effect to the patient directly produced by the device during the surgery
Feasibility of Mobilization
Time frame: Intra-operative
Ability to adequately mobilize the organ during the surgery

Results and safety

Results posted to the registry on 25 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Use of Levita Magnetics Grasper	50	50

Primary outcome: Safety Assessment of AEs

Time frame: During surgery. Count of participants. Unit: Participants

Measure	Use of Levita Magnetics Grasper n = 50
No device related adverse events	50
Device related adverse events	0

Primary outcome: Feasibility of Mobilization

Time frame: Intra-operative. Count of participants. Unit: Participants

Measure	Use of Levita Magnetics Grasper n = 50
Organ adequately mobilized	50
Excellent quality of exposure	45
Sufficient quality of exposure	5
Insufficient quality of exposure	0

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Use of Levita Magnetics Grasper	2 of 50 (4%)	19 of 50 (38%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27759614Rivas 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.

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Not yet recruitingObservational study
Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Use of Levita Magnetics Grasper in people with Benign Gallbladder Disease, run by Levita Magnetics at 3 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Assessment of AEs (time frame: During surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02049983, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.