ClinicalTrials.gg
Active, not recruitingNCT05642663Updated Sep 5, 2024

Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

An observational study in Obesity, sponsored by Scitech Produtos Medicos Ltda. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.

Sponsored by Scitech Produtos Medicos Ltda · Observational

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Study type
Observational
Model
Other
Time perspective
Other
Enrollment
300
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 285 studies in Obesity with a site in Brazil — 41 open to participants now, 62 under way, 27 of them phase 3. Obesity · Brazil.

Planned enrollment
10th of 32
300 · median 55
Started
2023
with 16 others
Observational
32 of 285
2 open now
Primary completion
2024-07
later than 4 of 61 live
Registered
211th of 285
by date

Among the 285 studies in Obesity with a site in Brazil, this one is the 10th largest by planned enrollment of the 32 observational ones that give a count, is one of 17 that started in 2023, is one of 32 observational ones, reaches primary completion later than 4 of the 61 other live ones, and was the 211th registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

41 of the 285 studies in Obesity with a site in Brazil are open now. Recruiting first, the newest first:

36 more — sign in →

All 41 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • Obesity

Browse trials for

Keywords

  • Stapler
  • ALTUS
  • Bariatric surgery
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with grade II obesity ( ≥ 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 form during a routine follow-up visit, authorizing the use of their surgery data and contact for follow-up.

Exclusion criteria

Exclusion Criteria:

  • Impossibility of collecting data related to the surgical procedure
  • Impossibility of contact with the patient to obtain the form
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceStapler

    Stapling performed with ALTUS Powered Stapler

06

What researchers measure

Primary outcomes

  1. Safety - Conversion to open surgery

    Number of conversions to open surgery during the index procedure

    Time frame: Intraoperative

  2. Safety - Number of reinterventions

    Number of reinterventions within 1 week after the procedure

    Time frame: Up to 1 week

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

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

    Time frame: 30 days

  4. Safety- Fistula formation

    Presence of fistula within 30 days after procedure

    Time frame: 30 days

  5. Safety - Stenosis

    Detection of stenosis within 90 days after procedure

    Time frame: 90 days

  6. Performance - Procedure Success

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

    Time frame: Intraoperative

  7. Performance - Cicatrization of staple line

    The absence of oozing/bleeding at the staple line

    Time frame: 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.

    Time frame: 12 months

07

Study locations

1 site
  • Hospital IGESP
    São Paulo, SP 01331010, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Jul 2024, 13 months.

Of 45 industry-sponsored observational studies under Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 45. This study's 13 months is below that.

Counting every sponsor, half of 838 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2022
First posted
Dec 8, 2022
StartActual
May 31, 2023
Primary completionActual
Jul 30, 2024
CompletionEst.
Jun 30, 2025
Last update
Sep 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05642663
Lead sponsor
Scitech Produtos Medicos Ltda
Responsible party
Sponsor
First posted
Dec 8, 2022
Start date
May 31, 2023
Primary completion
Jul 30, 2024
Completion
Jun 30, 2025 (estimated)
Last update
Sep 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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