Gastrointestinal Surgery
Conditions
Brief summary
The purpose of this observational study is to evaluate the safety and performance of the easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit from EziSurg Medical in gastrointestinal surgery. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications retrospectively.
Interventions
DEVICEeasyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit
The Staplers are available in 260mm, 350mm and 440mm lengths. Loading Units for Single Use are available in eight staple sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 2.0-2.5-3.5mm and 3.5-3.8-4.1mm, 3.8-4.1-4.4mm.
Sponsors
Ezisurg Medical Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age at study entry is at least 18 years. * The operation involves the application of easyEndoTM Lite Stapler and Loading Unit for tissue cutting and suturing.
Exclusion criteria
* Pregnancy. * Emergency operation (such as acute intestinal obstruction and gastrointestinal perforation). * Assessed by the investigator, whose condition is poor and cannot tolerate the surgery. * History of gastrointestinal surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| stapling success rate | Perioperative/Periprocedura |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | Perioperative/Periprocedural | — |
| Technical success rate | Perioperative/Periprocedural | defined as completion of gastrointestinal surgery as intended without technical difficulties and/or without conversion to open laparotomy |
Countries
Lebanon
Outcome results
None listed