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Clinical Trials/NCT06743256
NCT06743256RecruitingNot Applicable

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

Levita Magnetics4 sites in 1 country50 target enrollmentStarted: December 30, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Locations
4
Primary Endpoint
Number of Participants with Device and/or Procedure Related Adverse Events

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Individuals with BMI higher than 60 kg/m
  • 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.
  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Levita Magnetics
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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