ObesityNCT05642663
Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
An observational study of Obesity, run by Scitech Produtos Medicos SA at 1 site in Brazil.
Trial summary
Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Stapler
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 31 May 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (18 years or older), who underwent bariatric surgery with the use of Altus Powered Stapler
Who may be able to join
- 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.
Who cannot join
- Impossibility of collecting data related to the surgical procedure
- Impossibility of contact with the patient to obtain the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Stapler
- Keywords
- Stapler, ALTUS, Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaplerDevice
Stapling performed with ALTUS Powered Stapler
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Conversion to open surgery
Number of conversions to open surgery during the index procedure
Measured: Intraoperative
Safety - Number of reinterventions
Number of reinterventions within 1 week after the procedure
Measured: 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
Measured: 30 days
Safety- Fistula formation
Presence of fistula within 30 days after procedure
Measured: 30 days
Safety - Stenosis
Detection of stenosis within 90 days after procedure
Measured: 90 days
Performance - Procedure Success
Defined by completion of technique with the device for its intended use
Measured: Intraoperative
Performance - Cicatrization of staple line
The absence of oozing/bleeding at the staple line
Measured: 90 days
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start31 May 2023
- Primary completion30 Jul 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642663
- Sponsor's protocol ID
- SCI-GE-001
- Status last verified
- Sep 2024
- First submitted
- 18 Nov 2022
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing, Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05642663
- Acronym / sponsor ID
- SCI-GE-001
- Conditions
- Obesity
- Keywords
- Stapler, ALTUS, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated patients | – | Device: StaplerPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18 years or older), who underwent bariatric surgery with the use of Altus Powered Stapler
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Impossibility of collecting data related to the surgical procedure
- Impossibility of contact with the patient to obtain the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StaplerStapling performed with ALTUS Powered Stapler | Device | Treated patients |
Primary outcome
Safety - Conversion to open surgery
Time frame: Intraoperative
Number of conversions to open surgery during the index procedure
Safety - Number of reinterventions
Time frame: Up to 1 week
Number of reinterventions within 1 week after the procedure
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
Safety- Fistula formation
Time frame: 30 days
Presence of fistula within 30 days after procedure
Safety - Stenosis
Time frame: 90 days
Detection of stenosis within 90 days after procedure
Performance - Procedure Success
Time frame: Intraoperative
Defined by completion of technique with the device for its intended use
Performance - Cicatrization of staple line
Time frame: 90 days
The absence of oozing/bleeding at the staple line
1 secondary outcome
Post-operative change in weight
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Scitech Produtos Medicos SA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Conversion to open surgery (time frame: Intraoperative). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.