Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial
Status: Terminated
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation, and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative morbidity (the presence of illness or disease). The findings will then be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: f
View:
• Scheduled to undergo an elective open or laparoscopic Whipple procedure
• At least 22 years of age.
• Karnofsky performance status greater than or equal to 80%.
• Able to understand and willing to sign a written informed consent document.
Locations
United States
Missouri
Washington University School of Medicine
Saint Louis
Time Frame
Start Date: 2015-01-01
Completion Date: 2017-08-23
Participants
Target number of participants: 44
Treatments
Active_comparator: Control Group
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
Experimental: Thunderbeat™
-In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
Authors
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine