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

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ClinicalTrials.gov Identifier: NCT03896061
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

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.

Condition or disease Intervention/treatment
Hemostasis Device: Laparoscopic sleeve 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).


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : December 20, 2019

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


Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who satisfy inclusion/exclusion criteria for informed consent to participate in the study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896061


Locations
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United States, Louisiana
Surgical Specialists of Louisiana Recruiting
Metairie, Louisiana, United States, 70001
Contact: Jennifer Perilloux    504-934-3000    JPerilloux@whyweight.com   
Sponsors and Collaborators
Ethicon, Inc.

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Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT03896061     History of Changes
Other Study ID Numbers: ESC-2018-01
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
URL: http://yoda.yale.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No