Trial Outcomes & Findings for ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection (NCT NCT01241565)

NCT ID: NCT01241565

Last Updated: 2014-07-03

Results Overview

Defined as \> 5 days by the Society for Thoracic Surgery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Day 30
• Results posted on: 2014-07-03

Participant Flow

Participant milestones

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology Single arm study, all patients will receive the study device.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection

Baseline characteristics by cohort

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=50 Participants Single arm study, all patients will receive the study device.
Age, Continuous	68.9 years STANDARD_DEVIATION 10.4 • n=5 Participants
Gender Female	30 participants n=5 Participants
Gender Male	17 participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 participants n=5 Participants
Race (NIH/OMB) Asian	2 participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants
Race (NIH/OMB) Black or African American	5 participants n=5 Participants
Race (NIH/OMB) White	40 participants n=5 Participants
Race (NIH/OMB) More than one race	0 participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Defined as > 5 days by the Society for Thoracic Surgery

Outcome measures

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=47 Participants Single arm study, all patients will receive the study device.
Incidence of Prolonged Air Leaks	5 participants

SECONDARY outcome

Timeframe: Day 30

As recorded on the air leak log.

Outcome measures

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=47 Participants Single arm study, all patients will receive the study device.
Incidence of Air Leaks	33 number of patients with air leaks

SECONDARY outcome

Timeframe: Day 30

Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.

Outcome measures

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=47 Participants Single arm study, all patients will receive the study device.
Duration of Air Leak	3.52 days Standard Deviation 4.42

SECONDARY outcome

Timeframe: Approximately Day 6

Outcome measures

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=47 Participants Single arm study, all patients will receive the study device.
Length of Hospital Stay	6.32 days Standard Deviation 5.59

SECONDARY outcome

Timeframe: Approximately Day 5

Chest tube duration was calculated as removal date - placement date + 1

Outcome measures

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=47 Participants Single arm study, all patients will receive the study device.
Duration of Chest Tube Following Surgery	5.02 days Standard Deviation 4.54

SECONDARY outcome

Timeframe: Day 30

Outcome measures

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=47 Participants Single arm study, all patients will receive the study device.
Incidence of Serosal Tearing	2 participants Interval 0.52 to 14.54

Adverse Events

ENDO GIA™ Stapler With TRI-STAPLE™ Technology

Serious events: 10 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=47 participants at risk Single arm study, all patients will receive the study device.
Cardiac disorders Atrial Fibrillation	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Cardiac disorders Tachycardia	2.1% 1/47 • Number of events 2 • Adverse events were collected up to 30 days post surgery.
Gastrointestinal disorders Colitis Ischaemic	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Gastrointestinal disorders Gastritis	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Infections and infestations Pneumonia	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Infections and infestations Tooth Abscess	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Nervous system disorders Cerebrovascular Accident	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Bronchopleural Fistula	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Haemothorax	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Hepatic Hydrothorax	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Hypercapnia	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Pulmonary Air Leakage	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.
Skin and subcutaneous tissue disorders Subcutaneous Emphysema	4.3% 2/47 • Number of events 2 • Adverse events were collected up to 30 days post surgery.
Vascular disorders Hypotension	2.1% 1/47 • Number of events 1 • Adverse events were collected up to 30 days post surgery.

Other adverse events

Measure	ENDO GIA™ Stapler With TRI-STAPLE™ Technology n=47 participants at risk Single arm study, all patients will receive the study device.
Cardiac disorders Cardiomegaly	6.4% 3/47 • Number of events 3 • Adverse events were collected up to 30 days post surgery.
Cardiac disorders Tachycardia	6.4% 3/47 • Number of events 3 • Adverse events were collected up to 30 days post surgery.
Infections and infestations Urinary Tract Infection	6.4% 3/47 • Number of events 3 • Adverse events were collected up to 30 days post surgery.
Injury, poisoning and procedural complications Incision Site Pain	6.4% 3/47 • Number of events 3 • Adverse events were collected up to 30 days post surgery.
Injury, poisoning and procedural complications Procedural Pain	6.4% 3/47 • Number of events 4 • Adverse events were collected up to 30 days post surgery.
Nervous system disorders Neuralgia	12.8% 6/47 • Number of events 6 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Atelectasis	59.6% 28/47 • Number of events 45 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Cough	8.5% 4/47 • Number of events 6 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.6% 5/47 • Number of events 6 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	6.4% 3/47 • Number of events 3 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.4% 3/47 • Number of events 3 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Lung Infiltration	23.4% 11/47 • Number of events 14 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	23.4% 11/47 • Number of events 13 • Adverse events were collected up to 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Pneumothorax	44.7% 21/47 • Number of events 23 • Adverse events were collected up to 30 days post surgery.
Skin and subcutaneous tissue disorders Subcutaneous Emphysema	42.6% 20/47 • Number of events 21 • Adverse events were collected up to 30 days post surgery.
Vascular disorders Hypotension	6.4% 3/47 • Number of events 3 • Adverse events were collected up to 30 days post surgery.

Additional Information

Noreen Fahey

Covidien

Phone: 203-821-4716

Email: noreen.fahey@covidien.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place