Hemostasis Clinical Trial
Official title:
A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.
Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST
system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.
Data collected for the study consists of videography imaging and audio. Video recordings (no
subject identifiers) will involve the use of two cameras providing:
1. Synchronized Internal and external views of devices used, including the hands of the
surgeon firing the endocutter; and
2. Audio of the procedure to record the motor noise of the device while firing (audio will
help identify the surgeon's pulsing technique during the procedure).
Surgeon satisfaction with transection technique will also be collected. Videography will be
evaluated for staple line hemostasis and need for surgical intervention at the staple line
(defined in Criteria for Evaluation).
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