Clinical trial NCT02500537: A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
Official title: A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-emergent, Abdominal or Thoracic Procedures
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.

Detailed description: The objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in subjects undergoing indicated abdominal or thoracic procedures.

Eligibility criteria: Inclusion Criteria:

1. The subject must be 18-80 years of age
2. The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
3. 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.
4. For thoracic subjects: the subject has a FEV1 ≥40%

Exclusion Criteria:

1. Subjects undergoing cardiac and vascular procedures
2. The procedure is an emergency procedure
3. The procedure is a revision/reoperation for the same indication
4. 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)
5. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
6. The subject is unable or unwilling to comply with the study requirements or follow-up schedule
7. 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
8. The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment
9. The subject is concurrently enrolled in an investigational drug or device research study

Primary outcomes:
measure: The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.
timeFrame: Through 30 Days
Secondary outcomes:
measure: Staple Line Assessment: Incidence of Staple Line Bleeding
timeFrame: Day 0
measure: Staple Line Assessment: Incidence of Leakage
timeFrame: Day 0
measure: Staple Line Assessment: Duration of Leakage, Post-Op
timeFrame: Participants will be followed for the duration of hospital stay, on average up to 5 days
measure: Staple Line Assessment: Incidence of Leakage; Post-Op
timeFrame: Participants will be followed for the duration of hospital stay, on average up to 5 days
measure: Staple Line Assessment: Incidence of Post-operative Infection
timeFrame: Participants will be followed for the duration of hospital stay, on average up to 5 days
measure: Staple Line Assessment:
timeFrame: Participants will be followed for the duration of hospital stay, on average up to 5 days post-op
measure: Incidence of Repeat Hospital Admissions for Procedural-related Complications
timeFrame: 30 Days following procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
affiliation: St Mary's Hospital, London
name: Ahmed Ahmed, PhD, FRCS
role: PRINCIPAL_INVESTIGATOR
References: