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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progel® Pleural Air Leak Sealant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progel® Pleural Air Leak Sealant | Device | Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | One (1) month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up | One (1) month | |
| Percentage of Air Leaks That Are Sealed or Reduced | Day 0 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Park, MD | Hackensack Meridian Health | Principal Investigator |
| John Snider, MD | Dean Foundation for Health, Research and Education, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic & Vascular Surgical Associates, PA | Jacksonville | Florida | United States | |||
| Jupiter Medical Center, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27955681 | Derived | Park BJ, Snider JM, Bates NR, Cassivi SD, Jett GK, Sonett JR, Toloza EM. Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks. J Cardiothorac Surg. 2016 Dec 12;11(1):168. doi: 10.1186/s13019-016-0563-3. |
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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)
Enrollment began in June 2013. 112 subjects were treated across 15 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Progel® Pleural Air Leak Sealant | Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 |
| Duration of Chest Tube Drainage | Day 0-46 |
| 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 | 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. | Baseline and One (1) Month Follow-up |
| Jupiter |
| Florida |
| United States |
| Baptist Hospital of Miami | Miami | Florida | United States |
| H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. | Tampa | Florida | United States |
| North Shore University Health System | Evanston | Illinois | United States |
| Mayo Clinic | Rochester | Minnesota | United States |
| Washington University | St Louis | Missouri | United States |
| Integrated Cardiology Group, LLC | Lincoln | Nebraska | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | United States |
| Trustees of Columbia University, NY - Presbyterian Hospital | New York | New York | United States |
| Greenville Hospital System | Greenville | South Carolina | United States |
| Baylor Research Institute | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | United States |
| INOVA Health Care Services | Falls Church | Virginia | United States |
| Dean Foundation for Health, Research, and Eduation, Inc | Madison | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Progel® Pleural Air Leak Sealant | Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of subjects reflects subjects who have completed 1-month follow-up visit or had device/procedure related AE before discontinuation. | Posted | Number | 90% Confidence Interval | percentage of participants | One (1) month follow-up |
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| Secondary | Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up | MITT Population | Posted | Number | 90% Confidence Interval | percentage of participants | One (1) month |
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| Secondary | Percentage of Air Leaks That Are Sealed or Reduced | Subjects in the mITT population | Posted | Number | 95% Confidence Interval | percentage of air leaks | Day 0 | Number of Air Leaks | Number of Air Leaks |
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| Secondary | Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery | Posted | Count of Participants | Participants | Day 0 |
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| Secondary | Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals | MITT population minus 1 subject with missing data. | Posted | Mean | Standard Deviation | Days | Day 0-46 |
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| Secondary | Duration of Chest Tube Drainage | MITT Population minus 1 subject with missing data | Posted | Mean | Standard Deviation | Days | Day 0-46 |
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| Secondary | Duration of Hospitalization (Length of Stay) | MITT Population minus 2 subjects who died prior to discharge | Posted | Mean | Standard Deviation | Days | Days 0-20 |
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| 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. | MITT Population minus 19 subjects with missing data at either baseline or 1 month post-procedure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and One (1) Month Follow-up |
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Adverse Events were collected through the one month follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Progel® Pleural Air Leak Sealant | Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant | 28 | 112 | 31 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 16.1 |
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| Myocardial Infarction | Cardiac disorders | MedDRA 16.1 |
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| Pericardial Effusion | Cardiac disorders | MedDRA 16.1 |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 16.1 |
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| Ileus | Gastrointestinal disorders | MedDRA 16.1 |
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| Multi-organ Failure | General disorders | MedDRA 16.1 |
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| Pneumonia | Infections and infestations | MedDRA 16.1 |
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| Urinary Tract Infection | Infections and infestations | MedDRA 16.1 |
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| Post-procedural Hemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 |
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| Hyponaturemia | Metabolism and nutrition disorders | MedDRA 16.1 |
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| Carcinoid Tumor Pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 |
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| Convulsion | Nervous system disorders | MedDRA 16.1 |
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| Depression | Psychiatric disorders | MedDRA 16.1 |
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| Bronchial Secretion Retention | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Bronchial Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Bronchopleural Fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Pneurmonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Pulmonary Air Leakage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Pulmonary Hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 16.1 |
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| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 16.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 16.1 |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Arrythmia Supraventricular | Cardiac disorders | MedDRA 16.1 |
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| Pain | General disorders | MedDRA 16.1 |
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| Urinary Tract Infection | Infections and infestations | MedDRA 16.1 |
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| Mental Status Changes | Psychiatric disorders | MedDRA 16.1 |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Pulmonary Air Leakage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
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| Hypotension | Vascular disorders | MedDRA 16.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Heimer | C.R. Bard Inc. | 401-825-8681 | Dawn.Heimer@crbard.com |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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