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

• Sponsor: Ethicon, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03896061
• Collaborator: (none)
• Enrollment: 62
• Locations: 3
• Actual Duration (Months): 8.5
• Patients Per Site: 20.7
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	Phase
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).

Study Design

• Study Type: Observational
• Actual Enrollment: 62 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: Apr 15, 2019
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Outcome Measures

Primary Outcome Measures

1. Occurrence of oozing/bleeding at the staple line [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surgical Specialists of Louisiana	Metairie	Louisiana	United States	70001
2	State University of New York at Buffalo	Buffalo	New York	United States	14203
3	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Ethicon, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT03896061
• Other Study ID Numbers: ESC-2018-01
• First Posted: Mar 29, 2019
• Last Update Posted: Jun 24, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jun 24, 2020