Pulmonary Disease
Conditions
Keywords
Pleural Air Leak, Pulmonary resection, Video Assisted, Robotic Assisted
Brief summary
The objective of this clinical study is to evaluate the safety of the Progel® PALS, including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic) surgeries. The data collected in this clinical study will supplement the Approved PMA P010047 Progel® PALS product.
Detailed description
This is a prospective, open label, multi-center clinical study designed to assess the safety of the Progel® PALS product, including the Extended Applicator Spray Tip, when used in Video Assisted and Robotic Assisted Thoracoscopic Surgery. The study will treat approximately 105 evaluable subjects at up to 15 U.S. sites. All subjects will provide informed consent prior to enrollment in the study. Patients who have met the initial screening criteria and who have a visible pleural air leak which requires treatment with a sealant, after standard closure techniques are used (standard sutures, staples or devices supplied by the hospital for thoracoscopic surgery) will be eligible for study participation. If the subject is treated, the surgeon will utilize Progel® PALS to the same sites originally treated with standard technique.
Interventions
DEVICEProgel® Pleural Air Leak Sealant
Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is willing and able to provide written informed consent. * Subject is scheduled for video assisted or robotic assisted thoracoscopic surgery for lung resection (i.e. lobectomy, bilobectomy, segmentectomy, and wedge resection/lung volume reduction), decortications or biopsy within 45 days of the screening evaluation. * Subject is ≥18 years of age. * Subject has a life expectancy ≥6 months. * Following lung resection, subject has at least one or more visible intraoperative air leaks, after standard closure techniques are applied, that requires treatment with pleural sealant. * Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including the follow-up visits.
Exclusion criteria
* Subject has undergone previous lung resection or previous use of a sealant for air leaks. * Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis. * Following lung resection, subject has intraoperative air leaks that require non-standard, visceral pleural closure (e.g. leak is too small or tissue is too fragile to use sutures/staples). * Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements. * Subject has known allergy to human albumin or any component in the Progel® PALS product. * Subject has an active or latent infection which is systemic or at the intended surgery site. * Subject has necrotic or friable borders of the defect that will not support secure suture fixation if use of sutures is required. * Subject is participating in another investigational drug or device trial. * Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding. * Subject is part of the site personnel directly involved with this study. * Subject is a family member of the investigational study staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device and/or Procedure-related Adverse Events | One (1) month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Air Leaks That Are Sealed or Reduced | Day 0 | — |
| Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery | Day 0 | — |
| Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals | Day 0-46 | — |
| Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up | One (1) month | — |
| Duration of Hospitalization (Length of Stay) | Days 0-20 | — |
| Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up | Baseline and One (1) Month Follow-up | 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. |
| Duration of Chest Tube Drainage | Day 0-46 | — |
Countries
United States
Participant flow
Recruitment details
Enrollment began in June 2013. 112 subjects were treated across 15 sites.
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| Progel® Pleural Air Leak Sealant Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Subject could not be contacted | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Progel® Pleural Air Leak Sealant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 73 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 67.1 years STANDARD_DEVIATION 11.21 |
| Region of Enrollment United States | 112 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 112 |
| serious Total, serious adverse events | 28 / 112 |
Outcome results
Primary
Rate of Device and/or Procedure-related Adverse Events
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.
Time frame: One (1) month follow-up
Population: Number of subjects reflects subjects who have completed 1-month follow-up visit or had device/procedure related AE before discontinuation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progel® Pleural Air Leak Sealant | Rate of Device and/or Procedure-related Adverse Events | 42.5 percentage of participants |
Secondary
Duration of Chest Tube Drainage
Time frame: Day 0-46
Population: MITT Population minus 1 subject with missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progel® Pleural Air Leak Sealant | Duration of Chest Tube Drainage | 4.3 Days | Standard Deviation 6.02 |
Secondary
Duration of Hospitalization (Length of Stay)
Time frame: Days 0-20
Population: MITT Population minus 2 subjects who died prior to discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progel® Pleural Air Leak Sealant | Duration of Hospitalization (Length of Stay) | 4.6 Days | Standard Deviation 3.48 |
Secondary
Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals
Time frame: Day 0-46
Population: MITT population minus 1 subject with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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
Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Progel® Pleural Air Leak Sealant | Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery | 55 Participants |
Secondary
Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up
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.
Time frame: Baseline and One (1) Month Follow-up
Population: MITT Population minus 19 subjects with missing data at either baseline or 1 month post-procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 9.2 |
| 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 | Physical Component Score | -6.5 units on a scale | Standard Deviation 9.98 |
Secondary
Percentage of Air Leaks That Are Sealed or Reduced
Time frame: Day 0
Population: Subjects in the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progel® Pleural Air Leak Sealant | Percentage of Air Leaks That Are Sealed or Reduced | 96.2 percentage of air leaks |
Secondary
Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up
Time frame: One (1) month
Population: MITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 |