N/A
Completed N=60
Endostapler Hemostasis Study
Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
Source: ClinicalTrials.gov NCT04149925 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Staple Line Bleeding — 2.08; 2.57 score on a scale — p=0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Staple Line Bleeding |
2.08; 2.57 | 0.01 sig |
| SECONDARY Staple Line Leaking |
0; 0; 30; 30 | — |
| SECONDARY Adverse Events |
0; 0; 30; 30 | — |
| SECONDARY Product Malfunction |
0; 0; 30; 30 | — |
| SECONDARY Blood Transfusion |
0; 0; 30; 30 | — |
| SECONDARY Pain Level |
1.8; 1.6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04149925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.