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Endostapler Hemostasis Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149925
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborator:
Surgical Specialists of Louisiana
Information provided by (Responsible Party):
Lexington Medical Inc.

Brief Summary:
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.

Condition or disease Intervention/treatment
Incidence of Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale Device: AEON Endostapler Device: Echelon Flex Powered Stapler

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Endostapler Hemostasis Study Protocol
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
AEON Endostapler
Stapling performed by AEON Endostapler
Device: AEON Endostapler
Surgery with AEON Endostapler

Echelon Flex Powered Stapler
Stapling performed by Echelon Flex Powered Stapler
Device: Echelon Flex Powered Stapler
Surgery with Echelon Flex Powered Stapler




Primary Outcome Measures :
  1. Staple Line Bleeding [ Time Frame: 10 seconds after last staple line ]
    Incidence of intraoperative staple line bleeding as measured by the provided bleeding severity scale


Secondary Outcome Measures :
  1. Staple Line Leaking [ Time Frame: 1 month following procedure ]
    Incidence of postoperative leakage during one-month monitoring period following procedure

  2. Adverse Events [ Time Frame: During surgery ]
    Incidence of reported device-related adverse events

  3. Product Malfunction [ Time Frame: During surgery ]
    Incidence of product malfunction during procedure

  4. Blood Transfusion [ Time Frame: Within 72 hours of surgery start ]
    Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time

  5. Pain level [ Time Frame: 1 week following procedure ]
    Postoperative pain level as measured by a standard pain severity scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
See above
Criteria

Inclusion Criteria:

  • Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form
  • Informed consent for study obtained and signed from each subject

Exclusion Criteria:

  • Planned open surgical approach
  • Prior bariatric operation (i.e. revisional bariatric surgery)
  • Use of staple line reinforcement material (buttress)
  • Patients taking anticoagulants
  • Patients under the age of 18 on the date of the surgery

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): NCT04149925


Contacts
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Contact: Annette Dunn, BSE 480-313-8505 annette@lexington-med.com
Contact: Rainer Maas, MBA, BSEE 978-273-1946 rainer@lexington-med.com

Locations
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United States, Louisiana
Avala Hospital Recruiting
Covington, Louisiana, United States, 70433
Contact: Jennifer Perilloux    504-934-3000      
Crescent City Surgical Centre Recruiting
Metairie, Louisiana, United States, 70001
Contact: Jennifer Perilloux    504-934-3000      
Southern Surgical Hospital Recruiting
Slidell, Louisiana, United States, 70458
Contact: Jennifer Perilloux    504-934-3000      
Sponsors and Collaborators
Lexington Medical Inc.
Surgical Specialists of Louisiana

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Responsible Party: Lexington Medical Inc.
ClinicalTrials.gov Identifier: NCT04149925    
Other Study ID Numbers: Endostapler01
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Hemostatics
Coagulants