Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

N/AActive Not RecruitingNCT05642663

Scitech Produtos Medicos Ltda300 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Obesity

Interventions

StaplerDEVICE

Stapling performed with ALTUS Powered Stapler

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital IGESP

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Safety - Conversion to open surgery

Number of conversions to open surgery during the index procedure

Time frame: Intraoperative

Safety - Number of reinterventions

Number of reinterventions within 1 week after the procedure

Time frame: Up to 1 week

Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding

Presence of complications of anastomotic leaking and intraluminal/intraperitoneal bleeding within 30 days after procedure

Time frame: 30 days

Safety- Fistula formation

Presence of fistula within 30 days after procedure

Time frame: 30 days

Safety - Stenosis

Detection of stenosis within 90 days after procedure

Time frame: 90 days

Performance - Procedure Success

Defined by completion of technique with the device for its intended use

Time frame: Intraoperative

Performance - Cicatrization of staple line

The absence of oozing/bleeding at the staple line

Time frame: 90 days

Secondary Outcomes

Post-operative change in weight

Defined by preoperative weight (kg) minus postoperative weight (kg) divided by ideal body weight (kg) at the end of 12 months.

Time frame: 12 months

Data from ClinicalTrials.gov

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