N/A
Completed N=100
A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
Non-emergent, Abdominal or Thoracic Procedures
Source: ClinicalTrials.gov NCT02500537 ↗
Enrolled (actual)
100
Serious AEs
17.0%
Results posted
Apr 2017
Primary outcomePrimary: The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures. — 2; 1 Device related adverse events
Summary
A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures. |
2; 1 | — |
| SECONDARY Staple Line Assessment: Incidence of Staple Line Bleeding |
0; 0 | — |
| SECONDARY Staple Line Assessment: Incidence of Leakage |
0; 3 | — |
| SECONDARY Staple Line Assessment: Duration of Leakage, Post-Op |
7.7 | — |
| SECONDARY Staple Line Assessment: Incidence of Leakage; Post-Op |
1 | — |
| SECONDARY Staple Line Assessment: Incidence of Post-operative Infection |
1; 4 | — |
| SECONDARY Staple Line Assessment: |
2; 0 | — |
| SECONDARY Incidence of Repeat Hospital Admissions for Procedural-related Complications |
3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must be 18-80 years of age
- The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
- The subject is undergoing an indicated primary abdominal or thoracic procedure where the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) will be used per its Instructions For Use (IFU)
- Thoracic procedures may include, but are not limited to, wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
- Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection.
- For thoracic subjects: the subject has a FEV1 ≥40%
Exclusion Criteria
- Subjects undergoing cardiac and vascular procedures
- The procedure is an emergency procedure
- The procedure is a revision/reoperation for the same indication
- Any female subject who is pregnant
a. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test (except for subjects who are surgically sterile or are post-menopausal for at least two years)
- Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
- The subject is unable or unwilling to comply with the study requirements or follow-up schedule
- The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
- The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment
- The subject is concurrently enrolled in an investigational drug or device research study
Data sourced from ClinicalTrials.gov (NCT02500537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.