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OpenTrials
Active, Not Recruiting

NCT Number: NCT05642663

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital IGESP

São Paulo, 01331010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stapler

Device

Stapling performed with ALTUS Powered Stapler

Primary outcomes

  1. Safety - Conversion to open surgery

    Time frame: Intraoperative

    Number of conversions to open surgery during the index procedure

  2. Safety - Number of reinterventions

    Time frame: Up to 1 week

    Number of reinterventions within 1 week after the procedure

  3. Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding

    Time frame: 30 days

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

  4. Safety- Fistula formation

    Time frame: 30 days

    Presence of fistula within 30 days after procedure

  5. Safety - Stenosis

    Time frame: 90 days

    Detection of stenosis within 90 days after procedure

  6. Performance - Procedure Success

    Time frame: Intraoperative

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

  7. Performance - Cicatrization of staple line

    Time frame: 90 days

    The absence of oozing/bleeding at the staple line

Secondary outcomes

  1. Post-operative change in weight

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Scitech Produtos Medicos SA

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 8, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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