Non-emergent, Abdominal or Thoracic Procedures
Conditions
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.
Interventions
DEVICEEndo GIA™ Reinforced Reload with Tri-Staple™ Technology
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)
Sponsors
Medtronic - MITG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures. | Through 30 Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staple Line Assessment: Incidence of Leakage | Day 0 | As measured by air leak test, or standard of care, as applicable |
| Staple Line Assessment: Duration of Leakage, Post-Op | Participants will be followed for the duration of hospital stay, on average up to 5 days | Duration of leakage based on chest tube drainage in days |
| Staple Line Assessment: Incidence of Leakage; Post-Op | Participants will be followed for the duration of hospital stay, on average up to 5 days | The incidence of leakage for abdominal procedures; Post-up |
| Staple Line Assessment: Incidence of Staple Line Bleeding | Day 0 | The incidence of staple line bleeding will be measured as ≥ 50 cc |
| Staple Line Assessment: | Participants will be followed for the duration of hospital stay, on average up to 5 days post-op | Number of additional intervention(s) to treat staple-line failure |
| Incidence of Repeat Hospital Admissions for Procedural-related Complications | 30 Days following procedure | Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure |
| Staple Line Assessment: Incidence of Post-operative Infection | Participants will be followed for the duration of hospital stay, on average up to 5 days | Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abdominal 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
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) | 60 |
| Thoracic Procedures Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) | 40 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Thoracic Procedures | Total | Abdominal Procedures |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 9.7 | 52.7 years STANDARD_DEVIATION 15.52 | 44.9 years STANDARD_DEVIATION 13.56 |
| Body Mass Index (BMI) | 27.9 kg/m2 STANDARD_DEVIATION 5.87 | 36.4 kg/m2 STANDARD_DEVIATION 10.73 | 44.3 kg/m2 STANDARD_DEVIATION 7.06 |
| FEV1 Score (thoracic) | 82.2 percent STANDARD_DEVIATION 20.41 | 82.2 percent STANDARD_DEVIATION 20.41 | — |
| Sex: Female, Male Female | 20 Participants | 61 Participants | 41 Participants |
| Sex: Female, Male Male | 20 Participants | 39 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 60 | 0 / 40 |
| other Total, other adverse events | 14 / 60 | 14 / 40 |
| serious Total, serious adverse events | 12 / 60 | 5 / 40 |
Outcome results
Primary
The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.
Time frame: Through 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdominal Procedures | The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures. | 2 Device related adverse events |
| Thoracic Procedures | The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures. | 1 Device related adverse events |
Secondary
Incidence of Repeat Hospital Admissions for Procedural-related Complications
Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure
Time frame: 30 Days following procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdominal Procedures | Incidence of Repeat Hospital Admissions for Procedural-related Complications | 3 participants |
| Thoracic Procedures | Incidence of Repeat Hospital Admissions for Procedural-related Complications | 2 participants |
Secondary
Staple Line Assessment:
Number of additional intervention(s) to treat staple-line failure
Time frame: Participants will be followed for the duration of hospital stay, on average up to 5 days post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdominal Procedures | Staple Line Assessment: | 2 participants |
| Thoracic Procedures | Staple Line Assessment: | 0 participants |
Secondary
Staple Line Assessment: Duration of Leakage, Post-Op
Duration of leakage based on chest tube drainage in days
Time frame: Participants will be followed for the duration of hospital stay, on average up to 5 days
Population: Thoracic patients only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Procedures | Staple Line Assessment: Duration of Leakage, Post-Op | 7.7 days | Standard Deviation 5.51 |
Secondary
Staple Line Assessment: Incidence of Leakage
As measured by air leak test, or standard of care, as applicable
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdominal Procedures | Staple Line Assessment: Incidence of Leakage | 0 incidences of leakage |
| Thoracic Procedures | Staple Line Assessment: Incidence of Leakage | 3 incidences of leakage |
Secondary
Staple Line Assessment: Incidence of Leakage; Post-Op
The incidence of leakage for abdominal procedures; Post-up
Time frame: Participants will be followed for the duration of hospital stay, on average up to 5 days
Population: Abdominal patients only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdominal Procedures | Staple Line Assessment: Incidence of Leakage; Post-Op | 1 participants |
Secondary
Staple Line Assessment: Incidence of Post-operative Infection
Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients
Time frame: Participants will be followed for the duration of hospital stay, on average up to 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdominal Procedures | Staple Line Assessment: Incidence of Post-operative Infection | 1 participants |
| Thoracic Procedures | Staple Line Assessment: Incidence of Post-operative Infection | 4 participants |
Secondary
Staple Line Assessment: Incidence of Staple Line Bleeding
The incidence of staple line bleeding will be measured as ≥ 50 cc
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdominal Procedures | Staple Line Assessment: Incidence of Staple Line Bleeding | 0 incidences of staple line bleeding |
| Thoracic Procedures | Staple Line Assessment: Incidence of Staple Line Bleeding | 0 incidences of staple line bleeding |