Upper Gastrointestinal Laparoscopic SurgeryNCT07293611
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
A study testing Levita Magnetic Surgical System in people with Upper Gastrointestinal Laparoscopic Surgery, run by Levita Magnetics at 2 sites in Chile.
Trial summary
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Laparoscopic Surgery
- What is being tested?
- Levita Magnetic Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChile
- Study dates
- 30 Mar 2026to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI range of 20 to 60kg/m2
- Scheduled to undergo laparoscopic procedures
- Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study- required procedures
Who cannot join
- Individuals with pacemakers, defibrillators, or other electromedical implants
- Individuals with ferromagnetic implants
- American Society of Anesthesiologists (ASA) score of III or IV
- Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
- Clinical history of impaired coagulation confirmed by abnormal blood tests
- Individuals who have signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.)
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- Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
- Pregnant or wishes to become pregnant during the length of study participation
- Individual is not likely to comply with the follow-up evaluation schedule
- Participating in a clinical trial of another investigational drug or device
- Prisoner or under incarceration
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Clinica Colonial
Huechuraba, Santiago Metropolitan, 8580645
Hospital Luis Tisne
Peñalolén, Santiago Metropolitan, 7930124
About this study
Official title: Prospective, Multicenter, Single-arm, Open-label Study to Assess the Safety and Feasibility of the Levita Magnetic Surgical System for Reduced Port in Upper Gastrointestinal Laparoscopic Procedures
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
- Being tested
- Levita Magnetic Surgical System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levita Magnetic Surgical SystemDevice
The Magnetic Surgical System (MSS), which was cleared for market in the U.S. most recently per 510(k) K252435 and is commercially available in Chile, is composed of two hand-held instruments: a Magnetic Grasper and an external Magnetic Controller.
The Magnetic Grasper is comprised of two main components: a detachable Grasper Tip and a Shaft. The detachable Grasper Tip provided with the Magnetic Grasper is 6.5cm in length. An optional 12.5cm length detachable Grasper Tip may be used as a replacement for the 6.5cm Grasper Tip and can be used with the Shaft interchangeably. The Magnetic Controller is a single unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip.
In this study the 6.5 Grasper Tip will be used.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Surgical System in laparoscopic upper gastrointestinal procedures | Experimental | Not described Receives: Device: Levita Magnetic Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Device and/or Procedure Related Adverse Events
Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Measured: From enrollment to end of follow up at 30 days.
Average Number of Ports
Ability to adequately retract the stomach, omentum, and small bowel to achieve effective exposure of the target tissue. Adequate retraction will be deemed to be achieved if an additional port that is typically used for retraction and exposure of target tissues can be eliminated.
Measured: During index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start30 Mar 2026
- Primary completion5 May 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal Laparoscopic SurgeryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levita Magnetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293611
- Sponsor's protocol ID
- LVT011
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-arm, Open-label Study to Assess the Safety and Feasibility of the Levita Magnetic Surgical System for Reduced Port in Upper Gastrointestinal Laparoscopic Procedures
- ClinicalTrials.gov ID
- NCT07293611
- Acronym / sponsor ID
- LVT011
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Levita MagneticsIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Surgical System in laparoscopic upper gastrointestinal procedures | Experimental | Device: Levita Magnetic Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI range of 20 to 60kg/m2
- Scheduled to undergo laparoscopic procedures
- Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study- required procedures
Key exclusion criteria (11 listed)
- Individuals with pacemakers, defibrillators, or other electromedical implants
- Individuals with ferromagnetic implants
- American Society of Anesthesiologists (ASA) score of III or IV
- Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
- Clinical history of impaired coagulation confirmed by abnormal blood tests
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 |
|---|---|---|
| Levita Magnetic Surgical SystemThe Magnetic Surgical System (MSS), which was cleared for market in the U.S. most recently per 510(k) K252435 and is commercially available in Chile, is composed of two hand-held instruments: a Magnetic Grasper and an external Magnetic Controller. The Magnetic Grasper is comprised of two main components: a detachable Grasper Tip and a Shaft. The detachable Grasper Tip provided with the Magnetic Grasper is 6.5cm in length. An optional 12.5cm length detachable Grasper Tip may be used as a replacement for the 6.5cm Grasper Tip and can be used with the Shaft interchangeably. The Magnetic Controller is a single unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip. In this study the 6.5 Grasper Tip will be used. | Device | Magnetic Surgical System in laparoscopic upper gastrointestinal procedures |
Primary outcome
Number of Participants with Device and/or Procedure Related Adverse Events
Time frame: From enrollment to end of follow up at 30 days.
Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Average Number of Ports
Time frame: During index procedure.
Ability to adequately retract the stomach, omentum, and small bowel to achieve effective exposure of the target tissue. Adequate retraction will be deemed to be achieved if an additional port that is typically used for retraction and exposure of target tissues can be eliminated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levita Magnetic Surgical System in people with Upper Gastrointestinal Laparoscopic Surgery, run by Levita Magnetics at 2 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 3 inclusion and 11 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Device and/or Procedure Related Adverse Events (time frame: From enrollment to end of follow up at 30 days.). 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?
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 13 Jul 2026.