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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.

Tracking Information
First Submitted Date March 12, 2019
First Posted Date March 29, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date April 15, 2019
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03896061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
Official Title A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
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.
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).

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who satisfy inclusion/exclusion criteria for informed consent to participate in the study.
Condition Hemostasis
Intervention Device: Laparoscopic sleeve procedures
Laparoscopic sleeve procedures with powered stapler
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 28, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 20, 2019
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03896061
Other Study ID Numbers ESC-2018-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
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
Responsible Party Ethicon, Inc.
Study Sponsor Ethicon, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Ethicon, Inc.
Verification Date September 2019