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Not Yet Recruiting
NCT05642663
Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
Conditions: Obesity
Sex: All
Ages: 18 Years – N/A
Enrollment: 300
Sponsor: Scitech Produtos Medicos Ltda
Location: Brazil
Summary
Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.
Eligibility Criteria
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 procedureImpossibility of contact with the patient to obtain the informed consent form
Source: ClinicalTrials.gov (NCT05642663). StuddyBuddy aggregates publicly available trial information.
