Gynecological Laparoscopic SurgeryNCT06743256
Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures
A study testing Surgical System in people with Gynecological 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 gynecological surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Laparoscopic Surgery
- What is being tested?
- Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChile
- Study dates
- 30 Dec 2024to 4 Jun 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Having a BMI of at least 20 kg/m2
- Scheduled to undergo elective gynecological procedure
- 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 BMI higher than 60 kg/m2.
- Emergency procedures (e.g., ectopic pregnancy, severe bleeding).
- Significant comorbidities: e.g. cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
- Individuals with pacemakers, defibrillators, or other electromedical implants.
- Individuals with ferromagnetic implants.
- Clinical history of impaired coagulation confirmed by abnormal blood tests.
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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.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Clinico San Borja Arriaran
Peñalolén, Santiago Metropolitan
Hospital Santiago Oriente "Dr. Luis Tisné Brousse"
Peñalolén, Santiago Metropolitan
About this study
Official title: Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures
A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.
- Conditions
- Gynecological Laparoscopic Surgery
- Being tested
- Surgical System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical SystemDevice
Levita Magnetic Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Surgical System in laparoscopic gynecological procedures | Experimental | Not described Receives: Device: 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 uterus, adnexal organs, and peri uterine tissue to achieve an 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 2024
- Study start30 Dec 2024
- Primary completion28 Apr 2025
- Study completion4 Jun 2025
Why it stopped: The study was terminated early by the sponsor due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological 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
- 12 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
- NCT06743256
- Sponsor's protocol ID
- LVT010
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2024
- Last updated
- 27 Feb 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures
- ClinicalTrials.gov ID
- NCT06743256
- Acronym / sponsor ID
- LVT010
- Conditions
- Gynecological Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the sponsor due to slow enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Levita MagneticsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 19 Dec 2024 (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 gynecological 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 gynecological procedures | Experimental | Device: Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Having a BMI of at least 20 kg/m2
- Scheduled to undergo elective gynecological procedure
- 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 (10 listed)
- Individuals with BMI higher than 60 kg/m2.
- Emergency procedures (e.g., ectopic pregnancy, severe bleeding).
- Significant comorbidities: e.g. cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
- Individuals with pacemakers, defibrillators, or other electromedical implants.
- Individuals with ferromagnetic implants.
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 |
|---|---|---|
| Surgical SystemLevita Magnetic Surgical System | Device | Magnetic Surgical System in laparoscopic gynecological 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 uterus, adnexal organs, and peri uterine tissue to achieve an 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 was stopped early (reason given: The study was terminated early by the sponsor due to slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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 Surgical System in people with Gynecological 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 27 Feb 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 was stopped early (reason given: The study was terminated early by the sponsor due to slow enrollment.). Results are not available in the source record.
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 27 Feb 2026.