ProstatectomyNCT03624465
Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
A study testing Levita Magnetic Surgical System in people with Prostatectomy, 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 prostatectomy surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatectomy
- 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
- 1 siteChile
- Study dates
- 13 Aug 2018to 25 Mar 2019
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age
- Subject is scheduled to undergo elective prostatectomy surgery
Who cannot join
- Significant comorbidities
- Subjects with pacemakers, defibrillators, or other electromedical implants
- Subjects with ferromagnetic implants
- Clinical history of impaired coagulation
- Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
- Subject is not likely to comply with the follow-up evaluation schedule
- Subject is participating in another clinical trial
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 prostatectomy surgery.
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 prostatectomy surgery.
- Conditions
- Prostatectomy
- 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
Device for use as a surgical tool.
| Study group | Role | What they receive |
|---|---|---|
| Levita Magnetic Surgical System | Experimental | Levita Magnetic Surgical System use of surgical tool 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 Tools Required to Retract the Prostate During Procedure
Ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure.
Measured: During planned prostatectomy procudure
Incidence of Device Related Adverse Events (Safety)
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Measured: Through 30 days post prostatectomy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start13 Aug 2018
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
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.
- Other trials for ProstatectomyStudies 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
- Investigators
- Matthew Gettman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624465
- Sponsor's protocol ID
- CP005
- Status last verified
- Dec 2024
- First submitted
- 7 Aug 2018
- Last updated
- 1 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
- ClinicalTrials.gov ID
- NCT03624465
- Acronym / sponsor ID
- CP005
- Conditions
- Prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Levita MagneticsIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 12 Dec 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 prostatectomy surgery.
Detailed description
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levita Magnetic Surgical System | Experimental | Device: Levita Magnetic Surgical SystemLevita Magnetic Surgical System use of surgical tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is at least 18 years of age
- Subject is scheduled to undergo elective prostatectomy surgery
Key exclusion criteria (7 listed)
- Significant comorbidities
- Subjects with pacemakers, defibrillators, or other electromedical implants
- Subjects with ferromagnetic implants
- Clinical history of impaired coagulation
- Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
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 SystemDevice for use as a surgical tool. | Device | Levita Magnetic Surgical System |
Primary outcome
Number of Tools Required to Retract the Prostate During Procedure
Time frame: During planned prostatectomy procudure
Ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure.
Incidence of Device Related Adverse Events (Safety)
Time frame: Through 30 days post prostatectomy 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 1 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Matthew Gettman, MD principal investigator
Mayo Clinic
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 Prostatectomy, 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 7 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 1 Jan 2025. 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 12 Dec 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 of Tools Required to Retract the Prostate During Procedure (time frame: During planned prostatectomy procudure). 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 1 Jan 2025.