Trial Outcomes & Findings for A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology (NCT NCT02500537)
NCT ID: NCT02500537
Last Updated: 2017-04-04
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Through 30 Days
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
40
|
|
Overall Study
COMPLETED
|
57
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
FEV1 Score is captured for the thoracic population
Baseline characteristics by cohort
| Measure |
Abdominal Procedures
n=60 Participants
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)
|
Thoracic Procedures
n=40 Participants
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)
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 13.56 • n=60 Participants
|
64.6 years
STANDARD_DEVIATION 9.7 • n=40 Participants
|
52.7 years
STANDARD_DEVIATION 15.52 • n=100 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=60 Participants
|
20 Participants
n=40 Participants
|
61 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=60 Participants
|
20 Participants
n=40 Participants
|
39 Participants
n=100 Participants
|
|
Body Mass Index (BMI)
|
44.3 kg/m2
STANDARD_DEVIATION 7.06 • n=60 Participants
|
27.9 kg/m2
STANDARD_DEVIATION 5.87 • n=40 Participants
|
36.4 kg/m2
STANDARD_DEVIATION 10.73 • n=100 Participants
|
|
FEV1 Score (thoracic)
|
—
|
82.2 percent
STANDARD_DEVIATION 20.41 • n=40 Participants • FEV1 Score is captured for the thoracic population
|
82.2 percent
STANDARD_DEVIATION 20.41 • n=40 Participants • FEV1 Score is captured for the thoracic population
|
PRIMARY outcome
Timeframe: Through 30 DaysOutcome measures
| Measure |
Abdominal Procedures
n=60 Participants
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)
|
Thoracic Procedures
n=40 Participants
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)
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|---|---|---|
|
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
|
1 Device related adverse events
|
SECONDARY outcome
Timeframe: Day 0The incidence of staple line bleeding will be measured as ≥ 50 cc
Outcome measures
| Measure |
Abdominal Procedures
n=60 Participants
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)
|
Thoracic Procedures
n=40 Participants
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)
|
|---|---|---|
|
Staple Line Assessment: Incidence of Staple Line Bleeding
|
0 incidences of staple line bleeding
|
0 incidences of staple line bleeding
|
SECONDARY outcome
Timeframe: Day 0As measured by air leak test, or standard of care, as applicable
Outcome measures
| Measure |
Abdominal Procedures
n=60 Participants
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)
|
Thoracic Procedures
n=40 Participants
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)
|
|---|---|---|
|
Staple Line Assessment: Incidence of Leakage
|
0 incidences of leakage
|
3 incidences of leakage
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, on average up to 5 daysPopulation: Thoracic patients only
Duration of leakage based on chest tube drainage in days
Outcome measures
| Measure |
Abdominal Procedures
n=40 Participants
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)
|
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)
|
|---|---|---|
|
Staple Line Assessment: Duration of Leakage, Post-Op
|
7.7 days
Standard Deviation 5.51
|
—
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, on average up to 5 daysPopulation: Abdominal patients only
The incidence of leakage for abdominal procedures; Post-up
Outcome measures
| Measure |
Abdominal Procedures
n=60 Participants
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)
|
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)
|
|---|---|---|
|
Staple Line Assessment: Incidence of Leakage; Post-Op
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, on average up to 5 daysIncidence of post-operative infection at the staple line in abdominal patients and thoracic patients
Outcome measures
| Measure |
Abdominal Procedures
n=60 Participants
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)
|
Thoracic Procedures
n=40 Participants
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)
|
|---|---|---|
|
Staple Line Assessment: Incidence of Post-operative Infection
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, on average up to 5 days post-opNumber of additional intervention(s) to treat staple-line failure
Outcome measures
| Measure |
Abdominal Procedures
n=60 Participants
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)
|
Thoracic Procedures
n=40 Participants
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)
|
|---|---|---|
|
Staple Line Assessment:
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 30 Days following procedureIncidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure
Outcome measures
| Measure |
Abdominal Procedures
n=60 Participants
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)
|
Thoracic Procedures
n=40 Participants
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)
|
|---|---|---|
|
Incidence of Repeat Hospital Admissions for Procedural-related Complications
|
3 participants
|
2 participants
|
Adverse Events
Abdominal Procedures
Serious events: 12 serious events
Other events: 14 other events
Deaths: 2 deaths
Thoracic Procedures
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abdominal Procedures
n=60 participants at risk
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)
|
Thoracic Procedures
n=40 participants at risk
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)
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Infections and infestations
Infectious mononucleosis
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Infections and infestations
Lower respiratory tract infection
|
1.7%
1/60 • 30 days
|
5.0%
2/40 • 30 days
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Vascular disorders
Aortic rupture
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Vascular disorders
Haemorrhage
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
General disorders
Local swelling
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
General disorders
Complication of device removal
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Investigations
C-reactive protein increased
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
Other adverse events
| Measure |
Abdominal Procedures
n=60 participants at risk
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)
|
Thoracic Procedures
n=40 participants at risk
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)
|
|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
2/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Faecaloma
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Haematochezia
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
General disorders
Hyperthermia
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
General disorders
Pyrexia
|
0.00%
0/60 • 30 days
|
5.0%
2/40 • 30 days
|
|
Infections and infestations
Abdominal sepsis
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Infections and infestations
Infectious pleural effusion
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Infections and infestations
Lower respiratory tract infection
|
3.3%
2/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Infections and infestations
Oral herpes
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Infections and infestations
Pneumonia
|
3.3%
2/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
1.7%
1/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Injury, poisoning and procedural complications
Procedural complication
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/60 • 30 days
|
5.0%
2/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
1.7%
1/60 • 30 days
|
0.00%
0/40 • 30 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Infections and infestations
Incision site infection
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Investigations
C-reactive protein increased
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Investigations
White blood cell count increased
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/60 • 30 days
|
7.5%
3/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
0.00%
0/60 • 30 days
|
7.5%
3/40 • 30 days
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/60 • 30 days
|
5.0%
2/40 • 30 days
|
|
Surgical and medical procedures
Oxygen supplementation
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/60 • 30 days
|
2.5%
1/40 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60