A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
Levita Magnetic Surgical System
Hospital Clinico San Borja Arriaran
Peñalolén, Santiago Metropolitan, Chile
NOT_YET_RECRUITINGHospital Santiago Oriente "Dr. Luis Tisné Brousse"
Peñalolén, Santiago Metropolitan, Chile
RECRUITINGNumber 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.
Time frame: 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.
Time frame: During index procedure.
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