NCT05642663

Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

Post-marketing, Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Scitech Produtos Medicos SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Stapler	Stapling performed with ALTUS Powered Stapler

Timeline

• Start date: 2023-05-31
• Primary completion: 2024-07-30
• Completion: 2025-06-30
• First posted: 2022-12-08
• Last updated: 2024-09-05

Locations

1 site across 1 country: Brazil