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

Ethicon

Status: Completed

Conditions: Hemostasis

Treatments: Device: Laparoscopic sleeve procedures

Study type: Observational

Funder types: Industry

Identifiers

NCT03896061

ESC-2018-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 62 patients

Sex: All

Volunteers: No Healthy Volunteers

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