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Clinical Trial Summary

Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.


Clinical Trial Description

Up to 300 patients who underwent sleeve, bypass or revisional bariatric surgery with the use of Altus Powered Stapler will be included in the study. The stapler should be used according to the Instructions for Use and according to the local practice. The Altus Powered Stapler is used in open or laparoscopic surgeries and simultaneously cuts and staples soft tissues. In order to avoid great physical efforts by the physician and ensure excellent tissue suturing, the cutting and stapling mechanism is driven by the 12-volt battery that comes with the stapler. Patients will be followed by 7, 30 and 90 days and 12 months after the procedure, as per the research center's standard routine. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05642663
Study type Observational
Source Scitech Produtos Medicos Ltda
Contact Helber Alves
Phone +55 (11) 2125-8900
Email halves@scitechmed.com
Status Recruiting
Phase
Start date May 20, 2023
Completion date December 1, 2024

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