Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

Recruiting

• Conditions: Obesity
• Interventions: Device: Stapler

• Registration Number: NCT05642663
• Lead Sponsor: Scitech Produtos Medicos Ltda

Brief 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.

Study Timeline

• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18
• Study Start: 2023-05-20
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated patients	Stapler	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

Primary Outcome Measures

Name	Time	Method
Safety - Number of reinterventions	Up to 1 week	Number of reinterventions within 1 week after the procedure
Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding	30 days	Presence of complications of anastomotic leaking and intraluminal/intraperitoneal bleeding within 30 days after procedure
Safety- Fistula formation	30 days	Presence of fistula within 30 days after procedure
Safety - Stenosis	90 days	Detection of stenosis within 90 days after procedure
Performance - Procedure Success	Intraoperative	Defined by completion of technique with the device for its intended use
Performance - Cicatrization of staple line	90 days	The absence of oozing/bleeding at the staple line
Safety - Conversion to open surgery	Intraoperative	Number of conversions to open surgery during the index procedure

Secondary Outcome Measures

Name	Time	Method
Post-operative change in weight	12 months	Defined by preoperative weight (kg) minus postoperative weight (kg) divided by ideal body weight (kg) at the end of 12 months.

Trial Locations

Locations (1)

Hospital IGESP; 🇧🇷 São Paulo, SP, Brazil