Endostapler Sleeve Gastrectomy Study

Launched by LEXINGTON MEDICAL INC. · Nov 2, 2020

Keywords

ClinConnect Summary

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.

Gender

ALL

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 \<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