Hospital IGESP
São Paulo, 01331010, Brazil
NCT Number: NCT05642663
Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
São Paulo, 01331010, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stapling performed with ALTUS Powered Stapler
Time frame: Intraoperative
Number of conversions to open surgery during the index procedure
Time frame: Up to 1 week
Number of reinterventions within 1 week after the procedure
Time frame: 30 days
Presence of complications of anastomotic leaking and intraluminal/intraperitoneal bleeding within 30 days after procedure
Time frame: 30 days
Presence of fistula within 30 days after procedure
Time frame: 90 days
Detection of stenosis within 90 days after procedure
Time frame: Intraoperative
Defined by completion of technique with the device for its intended use
Time frame: 90 days
The absence of oozing/bleeding at the staple line
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.
Scitech Produtos Medicos SA
Industry
Post-marketing, Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
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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