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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Chile
Hospital Clinico San Borja Arriaran
NOT_YET_RECRUITING
Peñalolén
Hospital Santiago Oriente Dr. Luis Tisné Brousse
RECRUITING
Peñalolén
Contact Information
Primary
Vivian Soto
VSoto@Levita.com
+56958360507
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2026-06-07
Participants
Target number of participants: 50
Treatments
Experimental: Magnetic Surgical System in laparoscopic gynecological procedures
Related Therapeutic Areas
Sponsors
Leads: Levita Magnetics