A Videographic Study to Evaluate the Impact of a Pulsed F... | NCT03896061

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 12, 2019

First Submission Date that Met QC Criteria

Mar 28, 2019

First Posted Date

Mar 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2020

Last Update Posted Date

Jun 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic sleeve procedures	Device	Laparoscopic sleeve procedures with powered stapler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects who satisfy inclusion/exclusion criteria for informed consent to participate in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Surgical Specialists of Louisiana		Metairie	Louisiana	70001	United States
State University of New York at Buffalo

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

http://yoda.yale.edu

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.