Bariatric Surgery CandidateNCT03508674
Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
A study testing Levita Magnetic Surgical System in people with Bariatric Surgery Candidate, run by Levita Magnetics at 1 site in Chile.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- 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
- 54 participants
- Where
- 1 siteChile
- Study dates
- 20 Apr 2018to 6 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- scheduled to undergo bariatric procedure
Who cannot join
- Am Soc Anesthesiology score of III or IV
- significant comorbidities
- subjects contraindicated for use of magnetic system
- clinical history of impaired coagulation
- hepatic abnormality or anatomical abnormality
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures
Read the detailed description
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.
- Conditions
- Bariatric Surgery Candidate
- 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
use of surgical tool
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Levita Magnetic Surgical System Receives: Device: Levita Magnetic Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Types of Additional Tools Required to Mobilize the Liver During Procedure
The ability to mobilize the liver will be evaluated by recording the number and types of additional tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful.
Measured: During planned bariatric procedure. (approximately 2 hours on a single day.)
Number of Participants With Adverse Events and Device Related Adverse Events
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Measured: Through 30 days post bariatric procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start20 Apr 2018
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
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 Bariatric Surgery CandidateStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levita Magnetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dana Portenier, MD, Principal investigator, Duke Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508674
- Sponsor's protocol ID
- CP003
- Status last verified
- Sep 2024
- First submitted
- 16 Apr 2018
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodriguez Del Rey M, Davanzo C, Portenier D, Guerron AD. First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis. 2021 Jan;17(1):147-152. doi: 10.1016/j.soard.2020.08.017. Epub 2020 Aug 26.
PubMed 33011073
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
- ClinicalTrials.gov ID
- NCT03508674
- Acronym / sponsor ID
- CP003
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Levita MagneticsIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 16 Oct 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 evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures
Detailed description
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Levita Magnetic Surgical SystemLevita 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 (2 listed)
- at least 18 years of age
- scheduled to undergo bariatric procedure
Key exclusion criteria (5 listed)
- Am Soc Anesthesiology score of III or IV
- significant comorbidities
- subjects contraindicated for use of magnetic system
- clinical history of impaired coagulation
- hepatic abnormality or anatomical abnormality
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 Systemuse of surgical tool | Device | Intervention |
Primary outcome
Number and Types of Additional Tools Required to Mobilize the Liver During Procedure
Time frame: During planned bariatric procedure. (approximately 2 hours on a single day.)
The ability to mobilize the liver will be evaluated by recording the number and types of additional tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful.
Number of Participants With Adverse Events and Device Related Adverse Events
Time frame: Through 30 days post bariatric procedure
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33011073Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodriguez Del Rey M, Davanzo C, Portenier D, Guerron AD. First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis. 2021 Jan;17(1):147-152. doi: 10.1016/j.soard.2020.08.017. Epub 2020 Aug 26.
- Individual participant dataSharing planned: No
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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.
Dana Portenier, MD principal investigator
Duke Regional Hospital
1 site 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 Bariatric Surgery Candidate, run by Levita Magnetics at 1 site 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 2 inclusion and 5 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 16 Oct 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?
Number and Types of Additional Tools Required to Mobilize the Liver During Procedure (time frame: During planned bariatric procedure. (approximately 2 hours on a single day.)). 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 NCT03508674, 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 16 Oct 2024.