Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

Scitech Produtos Medicos

Status: Active, not recruiting

Conditions: Obesity

Treatments: Device: Stapler

Study type: Observational

Funder types: Industry

Identifiers

NCT05642663

SCI-GE-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with grade II obesity (BMI ≥ 35 kg/m^2) with one or more associated comorbidities;
• Patients with grade III obesity (BMI ≥ 40 kg/m^2) regardless of associated diseases;
• Patients who underwent sleeve, bypass and revisional bariatric surgery procedure with use of the Altus Powered Stapler;
• The patient must sign and date the informed consent form during a routine follow-up visit, authorizing the use of their surgery data and contact for follow-up.

Exclusion criteria

• Impossibility of collecting data related to the surgical procedure
• Impossibility of contact with the patient to obtain the informed consent form

Trial design

300 participants in 1 patient group

Treated patients

Description:

Patients with grade II (with one or more associated comorbidities) and grade III obesity who went through sleeve, bypass and revisional bariatric surgery procedure with the use of Altus Powered Stapler

Treatment:

Device: Stapler