Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Device: Stapler

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01331010
      • Hospital IGESP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (18 years or older), who underwent bariatric surgery with the use of Altus Powered Stapler

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated patients; 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	Device: Stapler; Stapling performed with ALTUS Powered Stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Conversion to open surgery	Number of conversions to open surgery during the index procedure	Intraoperative
Safety - Number of reinterventions	Number of reinterventions within 1 week after the procedure	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	30 days
Safety- Fistula formation	Presence of fistula within 30 days after procedure	30 days
Safety - Stenosis	Detection of stenosis within 90 days after procedure	90 days
Performance - Procedure Success	Defined by completion of technique with the device for its intended use	Intraoperative
Performance - Cicatrization of staple line	The absence of oozing/bleeding at the staple line	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Scitech Produtos Medicos Ltda

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Bariatric surgery; Stapler; ALTUS
• Other Study ID Numbers: SCI-GE-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No