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Endostapler Sleeve Gastrectomy Study

NCT ID: NCT04617574

Last Updated: 2021-10-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-07-10

Brief Summary

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The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.

Detailed Description

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Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. 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.

Conditions

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Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AEON Endostapler

Stapling performed with AEON Endostapler

AEON Endostapler

Intervention Type DEVICE

Surgery with AEON Endostapler

Endo GIA Reloads with Tri-Staple Technology

Stapling performed with Endo GIA Reloads with Tri-Staple Technology

Endo GIA Reloads with Tri-Staple Technology

Intervention Type DEVICE

Surgery with Endo GIA Reloads with Tri-Staple Technology

Interventions

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AEON Endostapler

Surgery with AEON Endostapler

Intervention Type DEVICE

Endo GIA Reloads with Tri-Staple Technology

Surgery with Endo GIA Reloads with Tri-Staple Technology

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing planned laparoscopic sleeve gastrectomy
* 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 Partial Thromboplastin Time (PTT) \>45sec, or Prothrombin Time (PT) \>15sec, or International Normalized Ratio (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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lexington Medical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Holyoke Medical Center

Holyoke, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Endostapler02

Identifier Type: -

Identifier Source: org_study_id