Hemostasis
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICELaparoscopic sleeve procedures
Laparoscopic sleeve procedures with powered stapler
Sponsors
Ethicon, Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Willingness to sign a Video, Audio and Digital Data Release consent for participation; and * Scheduled for a laparoscopic sleeve gastrectomy procedure.
Exclusion criteria
* Prophylactic use of buttressing material * Other staple line reinforcement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of oozing/bleeding at the staple line | 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 | 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. |
Countries
United States
Outcome results
None listed