Pulmonary DiseaseNCT01867658
Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
A study testing Progel® Pleural Air Leak Sealant in people with Pulmonary Disease, run by C. R. Bard at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Progel® Pleural Air Leak Sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Baylor Research Institute
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas
North Shore University Health System
Evanston, Illinois
INOVA Health Care Services
Falls Church, Virginia
Greenville Hospital System
Greenville, South Carolina
Hackensack University Medical Center
Hackensack, New Jersey
Cardiothoracic & Vascular Surgical Associates, PA
Jacksonville, Florida
Jupiter Medical Center, Inc.
Jupiter, Florida
Integrated Cardiology Group, LLC
Lincoln, Nebraska
Dean Foundation for Health, Research, and Eduation, Inc
Madison, Wisconsin
Baptist Hospital of Miami
Miami, Florida
Trustees of Columbia University, NY - Presbyterian Hospital
New York, New York
Mayo Clinic
Rochester, Minnesota
Washington University
St Louis, Missouri
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida
About this study
Official title: A Prospective Multi-Center Clinical Study to Evaluate the Safety of Progel® Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery
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.
Read the 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.
- Conditions
- Pulmonary Disease
- Being tested
- Progel® Pleural Air Leak Sealant
- Keywords
- Pleural Air Leak, Pulmonary resection, Video Assisted, Robotic Assisted
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progel® Pleural Air Leak SealantDevice
Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
| Study group | Role | What they receive |
|---|---|---|
| Progel® Pleural Air Leak Sealant | Experimental | Not described Receives: Device: Progel® Pleural Air Leak Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One (1) month follow-up
Secondary outcomes (7)
Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up
Measured: One (1) month
Percentage of Air Leaks That Are Sealed or Reduced
Measured: Day 0
Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery
Measured: Day 0
Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals
Measured: Day 0-46
Duration of Chest Tube Drainage
Measured: Day 0-46
Duration of Hospitalization (Length of Stay)
Measured: 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.
Measured: Baseline and One (1) Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard Park, MD, Principal investigator, Hackensack Meridian HealthJohn Snider, MD, Principal investigator, Dean Foundation for Health, Research and Education, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867658
- Sponsor's protocol ID
- NEO12-102
- Status last verified
- Feb 2017
- First submitted
- 3 May 2013
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27955681
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Clinical Study to Evaluate the Safety of Progel® Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery
- ClinicalTrials.gov ID
- NCT01867658
- Acronym / sponsor ID
- NEO12-102
- Conditions
- Pulmonary Disease
- Keywords
- Pleural Air Leak, Pulmonary resection, Video Assisted, Robotic Assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 11 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Progel® Pleural Air Leak Sealant | Experimental | Device: Progel® Pleural Air Leak Sealant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progel® Pleural Air Leak SealantVideo-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant | Device | Progel® Pleural Air Leak Sealant |
Primary outcome
Rate of Device and/or Procedure-related Adverse Events
Time frame: 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.
7 secondary outcomes
Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up
Time frame: One (1) month
Percentage of Air Leaks That Are Sealed or Reduced
Time frame: Day 0
Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery
Time frame: Day 0
Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals
Time frame: Day 0-46
Duration of Chest Tube Drainage
Time frame: Day 0-46
Duration of Hospitalization (Length of Stay)
Time frame: Days 0-20
Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up
Time frame: Baseline and One (1) Month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27955681Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Park, MD principal investigator
Hackensack Meridian Health
John Snider, MD principal investigator
Dean Foundation for Health, Research and Education, Inc
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progel® Pleural Air Leak Sealant in people with Pulmonary Disease, run by C. R. Bard at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Device and/or Procedure-related Adverse Events (time frame: One (1) month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.