NCT03896061

A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Hemostasis

Interventions

Type	Name	Description
DEVICE	Laparoscopic sleeve procedures	Laparoscopic sleeve procedures with powered stapler

Timeline

• Start date: 2019-04-15
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-03-29
• Last updated: 2020-06-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study