A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
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|ClinicalTrials.gov Identifier: NCT03896061|
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : June 24, 2020
|Condition or disease||Intervention/treatment|
|Hemostasis||Device: Laparoscopic sleeve 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:
- Synchronized Internal and external views of devices used, including the hands of the surgeon firing the endocutter; and
- 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).
|Study Type :||Observational|
|Actual Enrollment :||62 participants|
|Official Title:||A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy|
|Actual Study Start Date :||April 15, 2019|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
- Device: Laparoscopic sleeve procedures
Laparoscopic sleeve procedures with powered stapler
- Occurrence of oozing/bleeding at the staple line [ Time Frame: Intraoperative ]Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of oozing/bleeding at the staple line.
- Occurence of sugical interventions required to achieve hemostasis at the staple line [ Time Frame: Intraoperative ]Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of surgical interventions required to achieve hemostasis at the staple line.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896061
|United States, Louisiana|
|Surgical Specialists of Louisiana|
|Metairie, Louisiana, United States, 70001|
|United States, New York|
|State University of New York at Buffalo|
|Buffalo, New York, United States, 14203|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|