Status:
COMPLETED
The BlackBox Study
Lead Sponsor:
Olympus Corporation of the Americas
Collaborating Sponsors:
Unity Health Toronto
Conditions:
Laparoscopic Roux-en-y Gastric Bypass
Eligibility:
All Genders
18+ years
Brief Summary
This is a hypothesis generating pilot study to compare the impact of 2D versus 3D visualization on surgical performance, as measured by the OR BlackBox platform, during laparoscopic bariatric surgery.
Detailed Description
Data published in 2008 estimated the global number of surgical procedures performed annually as 234 million with a rate of major perioperative complications reported between 3% and 17% in industrializ...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Scheduled to undergo elective, primary roux-en-y gastric bypass surgery
- BMI of 35 to 54.9
- Willing and able to provide informed consent
Exclusion
- Previous open abdominal surgery
- Previous open or laparoscopic upper GI surgery
- Contraindicated for laparoscopic bariatric surgery
- Unable or unwilling to provide informed consent
Key Trial Info
Start Date :
February 6 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03252470
Start Date
February 6 2018
End Date
March 20 2019
Last Update
August 14 2019
Active Locations (1)
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1
St. Michael's Hospital, Division of Surgery
Toronto, Ontario, Canada, M5B