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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896061
• Other study ID #: ESC-2018-01
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2020
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemostasis

Intervention

Device:
• Laparoscopic sleeve procedures
Laparoscopic sleeve procedures with powered stapler

Locations

Country	Name	City	State
United States	State University of New York at Buffalo	Buffalo	New York
United States	Surgical Specialists of Louisiana	Metairie	Louisiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of oozing/bleeding at the staple line	Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of oozing/bleeding at the staple line.	Intraoperative
Primary	Occurence of sugical interventions required to achieve hemostasis at the staple line	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.	Intraoperative