Trial Outcomes & Findings for Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility (NCT NCT02234128)
NCT ID: NCT02234128
Last Updated: 2020-12-02
Results Overview
Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
72 Hours
Results posted on
2020-12-02
Participant Flow
Participant milestones
| Measure |
EVLP Double Lung Group
Toronto EVLP System™ administered to double lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
EVLP Single Lung Group
Toronto EVLP System™ administered to single lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
Control Group
Those patients receiving a single or double lung via conventional transplant.
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
52
|
|
Overall Study
COMPLETED
|
30
|
29
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
Baseline characteristics by cohort
| Measure |
EVLP Double Lung Group
n=35 Participants
Toronto EVLP System™ administered to double lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
EVLP Single Lung Group
n=31 Participants
Toronto EVLP System™ administered to single lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
Control Group
n=52 Participants
Those patients receiving a single or double lung via conventional transplant.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.9 years
n=5 Participants
|
65.2 years
n=7 Participants
|
61.6 years
n=5 Participants
|
62.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
31 participants
n=7 Participants
|
52 participants
n=5 Participants
|
118 participants
n=4 Participants
|
|
Lung Allocation Score
|
39.6 units on a scale
n=5 Participants
|
40.0 units on a scale
n=7 Participants
|
44.7 units on a scale
n=5 Participants
|
42.0 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: 72 HoursPrimary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.
Outcome measures
| Measure |
EVLP Double Lung Group
n=35 Participants
Toronto EVLP System™ administered to double lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
EVLP Single Lung Group
n=31 Participants
Toronto EVLP System™ administered to single lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
Control Group
n=52 Participants
Those patients receiving a single or double lung via conventional transplant.
|
|---|---|---|---|
|
Count of Participants With Primary Graft Dysfunction (PGD), Grade 3
|
8 Participants
|
8 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 30 DaysThe number of participants that survived to 30 days post-transplant.
Outcome measures
| Measure |
EVLP Double Lung Group
n=35 Participants
Toronto EVLP System™ administered to double lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
EVLP Single Lung Group
n=31 Participants
Toronto EVLP System™ administered to single lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
Control Group
n=52 Participants
Those patients receiving a single or double lung via conventional transplant.
|
|---|---|---|---|
|
Count of Participants Surviving
|
35 survivors
|
31 survivors
|
52 survivors
|
SECONDARY outcome
Timeframe: 0, 24, 48 & 72 HoursPGD Score (0-3) at 0, 24, 48 \& 72 hours post-transplant
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 HoursOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DaysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DaysOutcome measures
Outcome data not reported
Adverse Events
EVLP Double Lung Group
Serious events: 31 serious events
Other events: 35 other events
Deaths: 5 deaths
EVLP Single Lung Group
Serious events: 24 serious events
Other events: 30 other events
Deaths: 2 deaths
Control Group
Serious events: 41 serious events
Other events: 51 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
EVLP Double Lung Group
n=35 participants at risk
Toronto EVLP System™ administered to double lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
EVLP Single Lung Group
n=31 participants at risk
Toronto EVLP System™ administered to single lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
Control Group
n=52 participants at risk
Those patients receiving a single or double lung via conventional transplant.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
22.9%
8/35 • 1 year
Regular Investigator Assessment
|
19.4%
6/31 • 1 year
Regular Investigator Assessment
|
19.2%
10/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
17.1%
6/35 • 1 year
Regular Investigator Assessment
|
16.1%
5/31 • 1 year
Regular Investigator Assessment
|
9.6%
5/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
17.1%
6/35 • 1 year
Regular Investigator Assessment
|
12.9%
4/31 • 1 year
Regular Investigator Assessment
|
13.5%
7/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
17.1%
6/35 • 1 year
Regular Investigator Assessment
|
12.9%
4/31 • 1 year
Regular Investigator Assessment
|
7.7%
4/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
16.1%
5/31 • 1 year
Regular Investigator Assessment
|
3.8%
2/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Cytomegalovirus Viremia
|
8.6%
3/35 • 1 year
Regular Investigator Assessment
|
9.7%
3/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.6%
3/35 • 1 year
Regular Investigator Assessment
|
9.7%
3/31 • 1 year
Regular Investigator Assessment
|
7.7%
4/52 • 1 year
Regular Investigator Assessment
|
|
Cardiac disorders
Cardiac Arrest
|
8.6%
3/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Immune system disorders
Lung Transplant Rejection
|
11.4%
4/35 • 1 year
Regular Investigator Assessment
|
3.2%
1/31 • 1 year
Regular Investigator Assessment
|
13.5%
7/52 • 1 year
Regular Investigator Assessment
|
|
Nervous system disorders
Delerium
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
9.7%
3/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Pneumonia pseudomonal
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Immune system disorders
Transplant Rejection
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
3.2%
1/31 • 1 year
Regular Investigator Assessment
|
9.6%
5/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Septic shock
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
5.8%
3/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
5.8%
3/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
5.8%
3/52 • 1 year
Regular Investigator Assessment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
8.6%
3/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Influenza
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Postoperative wound infection
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Respiratory syncytial virus infection
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Injury, poisoning and procedural complications
Bronchial anastomosis complication
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
3.2%
1/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Injury, poisoning and procedural complications
Complications of transplanted lung
|
8.6%
3/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
3.8%
2/52 • 1 year
Regular Investigator Assessment
|
|
Nervous system disorders
Cerebrovascular accident
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
3.8%
2/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
3.2%
1/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Vascular disorders
Shock hemorrhagic
|
8.6%
3/35 • 1 year
Regular Investigator Assessment
|
3.2%
1/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
Other adverse events
| Measure |
EVLP Double Lung Group
n=35 participants at risk
Toronto EVLP System™ administered to double lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
EVLP Single Lung Group
n=31 participants at risk
Toronto EVLP System™ administered to single lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
|
Control Group
n=52 participants at risk
Those patients receiving a single or double lung via conventional transplant.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
12.9%
4/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
5.8%
3/52 • 1 year
Regular Investigator Assessment
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Immune system disorders
Drug hypersensitivity
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Immune system disorders
Lung transplant rejection
|
17.1%
6/35 • 1 year
Regular Investigator Assessment
|
32.3%
10/31 • 1 year
Regular Investigator Assessment
|
23.1%
12/52 • 1 year
Regular Investigator Assessment
|
|
Immune system disorders
Transplant rejection
|
22.9%
8/35 • 1 year
Regular Investigator Assessment
|
22.6%
7/31 • 1 year
Regular Investigator Assessment
|
28.8%
15/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Bronchitis
|
8.6%
3/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Bronchitis bacterial
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
9.6%
5/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Cytomegalovirus viremia
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
5.8%
3/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Diverticulitis
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Haemophilus infection
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Infectious pleural effusion
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Influenza
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
3.8%
2/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
28.6%
10/35 • 1 year
Regular Investigator Assessment
|
25.8%
8/31 • 1 year
Regular Investigator Assessment
|
15.4%
8/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Lung infection pseudomonal
|
22.9%
8/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
15.4%
8/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
9.7%
3/31 • 1 year
Regular Investigator Assessment
|
5.8%
3/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Respiratory tract infection bacterial
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
7.7%
4/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Rhinovirus infection
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
9.6%
5/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Transmission of an infectious agent via transplant
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
3.2%
1/31 • 1 year
Regular Investigator Assessment
|
7.7%
4/52 • 1 year
Regular Investigator Assessment
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
3/35 • 1 year
Regular Investigator Assessment
|
3.2%
1/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Injury, poisoning and procedural complications
Bronchial anastomosis complication
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Psychiatric disorders
Delirium
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
5.8%
3/52 • 1 year
Regular Investigator Assessment
|
|
Psychiatric disorders
Mental status changes
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Renal and urinary disorders
Acute kidney injury
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
11.4%
4/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
5.8%
3/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
3.2%
1/31 • 1 year
Regular Investigator Assessment
|
1.9%
1/52 • 1 year
Regular Investigator Assessment
|
|
Skin and subcutaneous tissue disorders
Decubitis ulcer
|
5.7%
2/35 • 1 year
Regular Investigator Assessment
|
0.00%
0/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
|
Vascular disorders
Deep vein thrombosis
|
2.9%
1/35 • 1 year
Regular Investigator Assessment
|
6.5%
2/31 • 1 year
Regular Investigator Assessment
|
0.00%
0/52 • 1 year
Regular Investigator Assessment
|
Additional Information
Michael Roberts, Director Regulatory Affairs
Lung Bioengineering Inc.
Phone: 2406502261
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60