Trial Outcomes & Findings for Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery (NCT NCT01867658)
NCT ID: NCT01867658
Last Updated: 2017-03-29
Results Overview
The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
207 participants
Primary outcome timeframe
One (1) month follow-up
Results posted on
2017-03-29
Participant Flow
Enrollment began in June 2013. 112 subjects were treated across 15 sites.
207 subjects were consented and 112 were treated with Progel® PALS. Of the subjects who were not treated, 69 failed to meet intra-operative inclusion criteria (54/94 screened video-assisted subjects and 15/87 screened robotic assisted subjects) and 11 did not have a video or robotics procedure performed (ie, converted to open thoracotomy)
Participant milestones
| Measure |
Progel® Pleural Air Leak Sealant
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Progel® Pleural Air Leak Sealant
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Death
|
2
|
|
Overall Study
Subject could not be contacted
|
1
|
Baseline Characteristics
Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
Baseline characteristics by cohort
| Measure |
Progel® Pleural Air Leak Sealant
n=112 Participants
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=5 Participants
|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One (1) month follow-upPopulation: Number of subjects reflects subjects who have completed 1-month follow-up visit or had device/procedure related AE before discontinuation.
The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.
Outcome measures
| Measure |
Progel® Pleural Air Leak Sealant
n=106 Participants
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Rate of Device and/or Procedure-related Adverse Events
|
42.5 percentage of participants
Interval 34.3 to 50.9
|
SECONDARY outcome
Timeframe: One (1) monthPopulation: MITT Population
Outcome measures
| Measure |
Progel® Pleural Air Leak Sealant
n=112 Participants
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up
|
49.1 percentage of participants
Interval 41.0 to 57.3
|
SECONDARY outcome
Timeframe: Day 0Population: Subjects in the mITT population
Outcome measures
| Measure |
Progel® Pleural Air Leak Sealant
n=133 Number of Air Leaks
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Percentage of Air Leaks That Are Sealed or Reduced
|
96.2 percentage of air leaks
Interval 91.4 to 98.8
|
SECONDARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Progel® Pleural Air Leak Sealant
n=112 Participants
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery
|
55 Participants
|
SECONDARY outcome
Timeframe: Day 0-46Population: MITT population minus 1 subject with missing data.
Outcome measures
| Measure |
Progel® Pleural Air Leak Sealant
n=111 Participants
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals
|
2.8 Days
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: Day 0-46Population: MITT Population minus 1 subject with missing data
Outcome measures
| Measure |
Progel® Pleural Air Leak Sealant
n=111 Participants
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Duration of Chest Tube Drainage
|
4.3 Days
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: Days 0-20Population: MITT Population minus 2 subjects who died prior to discharge
Outcome measures
| Measure |
Progel® Pleural Air Leak Sealant
n=110 Participants
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Duration of Hospitalization (Length of Stay)
|
4.6 Days
Standard Deviation 3.48
|
SECONDARY outcome
Timeframe: Baseline and One (1) Month Follow-upPopulation: MITT Population minus 19 subjects with missing data at either baseline or 1 month post-procedure.
The scale ranges from 0 (minimum score) to 100 (maximum) score. A higher the score represents a more favorable health rating. The SF-36 was completed at baseline before surgery and one month post index procedure; the change calculation for both mental and physical components is based on the difference in scores between these two time points.
Outcome measures
| Measure |
Progel® Pleural Air Leak Sealant
n=93 Participants
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up
Mental Component Score
|
-0.2 units on a scale
Standard Deviation 9.20
|
|
Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up
Physical Component Score
|
-6.5 units on a scale
Standard Deviation 9.98
|
Adverse Events
Progel® Pleural Air Leak Sealant
Serious events: 28 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Progel® Pleural Air Leak Sealant
n=112 participants at risk
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Cardiac disorders
Myocardial Infarction
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Cardiac disorders
Pericardial Effusion
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Gastrointestinal disorders
Ileus
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
General disorders
Multi-organ Failure
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Infections and infestations
Pneumonia
|
2.7%
3/112 • Adverse Events were collected through the one month follow-up period.
|
|
Infections and infestations
Urinary Tract Infection
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Injury, poisoning and procedural complications
Post-procedural Hemorrhage
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Metabolism and nutrition disorders
Hyponaturemia
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumor Pulmonary
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Nervous system disorders
Convulsion
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Psychiatric disorders
Depression
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Secretion Retention
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural Fistula
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.7%
3/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneurmonia Aspiration
|
1.8%
2/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.8%
2/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Air Leakage
|
6.2%
7/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
1.8%
2/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.89%
1/112 • Adverse Events were collected through the one month follow-up period.
|
Other adverse events
| Measure |
Progel® Pleural Air Leak Sealant
n=112 participants at risk
Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
|
|---|---|
|
General disorders
Pyrexia
|
10.7%
12/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.4%
6/112 • Adverse Events were collected through the one month follow-up period.
|
|
Cardiac disorders
Arrythmia Supraventricular
|
4.5%
5/112 • Adverse Events were collected through the one month follow-up period.
|
|
General disorders
Pain
|
2.7%
3/112 • Adverse Events were collected through the one month follow-up period.
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
4/112 • Adverse Events were collected through the one month follow-up period.
|
|
Psychiatric disorders
Mental Status Changes
|
2.7%
3/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
4/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.7%
3/112 • Adverse Events were collected through the one month follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Air Leakage
|
2.7%
3/112 • Adverse Events were collected through the one month follow-up period.
|
|
Vascular disorders
Hypotension
|
4.5%
5/112 • Adverse Events were collected through the one month follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60