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OpenTrials
Completed

NCT Number: NCT03896061

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

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.

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Key information

Conditions

Hemostasis

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical Specialists of Louisiana, Metairie, Louisiana, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic sleeve procedures

Device

Laparoscopic sleeve procedures with powered stapler

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2019
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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