Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

NCT05642663 | Active Not Recruiting

• 1 other identifier: SCI-GE-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Stapler; ALTUS; Bariatric surgery

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Post-operative change in weight

  12 months

Study Arms (1)

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

Interventions

Stapler DEVICE

Stapling performed with ALTUS Powered Stapler

Treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Impossibility of collecting data related to the surgical procedure
• Impossibility of contact with the patient to obtain the informed consent form

Sponsors & Collaborators

• Scitech Produtos Medicos Ltda: lead

Study Sites (1)

Hospital IGESP

São Paulo, São Paulo, 01331010, Brazil

Location

MeSH Terms

Conditions

Obesity

Interventions

Surgical Staplers

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Instruments; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 8, 2022
• Study Start: May 31, 2023
• Primary Completion: July 30, 2024
• Study Completion: June 30, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)