N/A
Completed N=60
Endostapler Sleeve Gastrectomy Study
Source: ClinicalTrials.gov NCT04617574 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Intraoperative Endoscopic Staple Line Bleeding Score — 1.63; 2.00 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Endoscopic Staple Line Bleeding Score |
1.63; 2.00 | — |
| PRIMARY Intraoperative Laparoscopic Staple Line Bleeding Score |
1.55; 1.98 | — |
| SECONDARY Number of Participants With Postoperative Leakage Requiring Intervention |
0; 0 | — |
| SECONDARY Number of Participants With Intraoperative or Postoperative Blood Transfusion |
0; 0 | — |
| SECONDARY Number of Participants With Reported Device-related Adverse Events |
0; 0 | — |
| SECONDARY Number of Participants With Product Malfunction |
0; 0 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT04617574). 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.