N/A N=60

Endostapler Sleeve Gastrectomy Study

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT04617574 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Intraoperative Endoscopic Staple Line Bleeding Score — 1.63; 2.00 score on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: AEON Endostapler (Device); Endo GIA Reloads with Tri-Staple Technology (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lexington Medical Inc.
Primary completion: Jun 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

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.