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Endostapler Gastric Bypass Study

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ClinicalTrials.gov Identifier: NCT04712526
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Lexington Medical Inc.

Brief Summary:
The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.

Condition or disease Intervention/treatment
Obesity Device: AEON Endostapler

Detailed Description:
Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

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




Primary Outcome Measures :
  1. Incidence of reported device-related adverse events [ Time Frame: Within 30-day post-operative period ]

Secondary Outcome Measures :
  1. Endoscopic staple line bleeding [ Time Frame: Within surgery ]
    Incidence of intraoperative staple line bleeding from endoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Endoscope Images (1: No bleeding, 5: Profuse Bleeding)

  2. Laparoscopic staple line bleeding [ Time Frame: Within surgery ]
    Incidence of intraoperative staple line bleeding from laparoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Laparoscope Images (1: No bleeding, 5: Profuse Bleeding)

  3. Incidence of intraoperative or postoperative blood transfusion [ Time Frame: Within 72 hours of surgery start time ]
  4. Incidence of product malfunction [ Time Frame: Within surgery ]


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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
25 subjects
Criteria

Inclusion Criteria:

  • Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
  • Informed consent for study obtained and signed from each subject

Exclusion Criteria:

  • Planned open surgical approach
  • Use of staple line reinforcement material (buttress)
  • Revision or other bariatric procedure
  • Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or PTT > 45sec, or PT> 15sec, or INR>1.5
  • Patients with active HIV or Hepatitis B
  • Patients under the age of 18 on the date of the surgery
  • Patients who are pregnant
  • Patients using tobacco products within the last 2 weeks prior to surgery date
  • Patients using cortisone or related products within the last 2 weeks prior to surgery date

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): NCT04712526


Contacts
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Contact: Annette Dunn 480-313-8505 annette@lexington-med.com

Locations
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United States, Massachusetts
Holyoke Medical Center Recruiting
Holyoke, Massachusetts, United States, 01040
Contact: Elana Davidson       davidson_elana@holyokehealth.com   
Principal Investigator: Yannis Raftopoulos, MD         
Sponsors and Collaborators
Lexington Medical Inc.
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Responsible Party: Lexington Medical Inc.
ClinicalTrials.gov Identifier: NCT04712526    
Other Study ID Numbers: Endostapler03
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: January 2021

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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