Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642663
• Other study ID #: SCI-GE-001
• Status: Recruiting
• Start date: May 20, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: Scitech Produtos Medicos Ltda
• Contact: Helber Alves
• Phone: +55 (11) 2125-8900
• Email: halves[@]scitechmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Stapler
Stapling performed with ALTUS Powered Stapler

Locations

Country	Name	City	State
Brazil	Hospital IGESP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

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