Lung CancerNCT01394978

NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

A study testing ProGEL Pleural Air Leak Sealant with standard surgical closure and ProGEL Pleural Air Leak Sealant without standard surgical closure in people with Lung Cancer and Lung Tumor, run by C. R. Bard at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Lung Tumor
What is being tested?: ProGEL Pleural Air Leak Sealant with standard surgical closure and ProGEL Pleural Air Leak Sealant without standard surgical closure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 444 participants
Where: 18 sitesUnited States
Study dates: Jun 2011to Feb 2016
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

Scheduled for an open thoracotomy for lung resection
Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery

Who cannot join

Pregnant or breast feeding
History of an allergic reaction to Human Serum Albumin
Has a significant clinical disease or condition
Had previous open thoracotomy procedures
Unable to participate in all necessary study activities due to physical or mental limitations

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

WellStar Research Institute
Atlanta, Georgia, 30060
Emory University
Atlanta, Georgia, 30322
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
St. Vincent Birmingham & St. Vincent East
Birmingham, Alabama, 35243
University of Alabama in Birmingham
Birmingham, Alabama, 35894
Mass General Hospital
Boston, Massachusetts, 02114
Brigham Womens' Hospital
Boston, Massachusetts, 02115
Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215
Indiana University
Indianapolis, Indiana, 46202
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46290
Jacksonville Center for Research
Jacksonville, Florida, 32207
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Dean Foundation for Health, Research and Education, Inc.
Madison, Wisconsin, 53715
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Swedish Cancer Institute
Seattle, Washington, 98104
Moffit Cancer Center
Tampa, Florida, 33612
UMass Memorial Medical
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure

Read the detailed description

Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.

Conditions: Lung Cancer, Lung Tumor
Being tested: Control, ProGEL Pleural Air Leak Sealant with standard surgical closure, ProGEL Pleural Air Leak Sealant without standard surgical closure
Keywords: Pleural air leak, Pulmonary resection, Open thoracotomy
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ControlOther
Standard surgical techniques including staples and sutures.
ProGEL Pleural Air Leak Sealant with standard surgical closureDevice
ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.
ProGEL Pleural Air Leak Sealant without standard surgical closureDevice
ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.

Study groups in NCT01394978
Study group	Role	What they receive
Control	Other	No treatment. Receives: Other: Control
ProGEL Pleural Air Leak Sealant with standard surgical closure	Experimental	Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant. Receives: Device: ProGEL Pleural Air Leak Sealant with standard surgical closure
ProGEL Pleural Air Leak Sealant without standard surgical closure	Experimental	Progel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma). Receives: Device: ProGEL Pleural Air Leak Sealant without standard surgical closure

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Endpoints
- Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome
- Renal adverse events
- Cardiac adverse events
- Death (all causes)
- Hospital readmission
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Feb 2016

First posted15 Jul 2011 (estimated)
Study startJun 2011
Primary completionFeb 2016
Study completionFeb 2016

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.
Other trials for Lung CancerStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 444 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01394978
Sponsor's protocol ID: NEO09-100
Status last verified: Jul 2021
First submitted: 13 Jul 2011
Last updated: 15 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure
ClinicalTrials.gov ID: NCT01394978
Acronym / sponsor ID: NEO09-100
Conditions: Lung Cancer, Lung Tumor
Keywords: Pleural air leak, Pulmonary resection, Open thoracotomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 444 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 15 Jul 2011 (estimated)
Results: Posted 11 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control	Other	Other: ControlNo treatment.
ProGEL Pleural Air Leak Sealant with standard surgical closure	Experimental	Device: ProGEL Pleural Air Leak Sealant with standard surgical closureStandard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant.
ProGEL Pleural Air Leak Sealant without standard surgical closure	Experimental	Device: ProGEL Pleural Air Leak Sealant without standard surgical closureProgel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Scheduled for an open thoracotomy for lung resection
Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery

Key exclusion criteria (5 listed)

Pregnant or breast feeding
History of an allergic reaction to Human Serum Albumin
Has a significant clinical disease or condition
Had previous open thoracotomy procedures
Unable to participate in all necessary study activities due to physical or mental limitations

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
ControlStandard surgical techniques including staples and sutures.	Other	Control
ProGEL Pleural Air Leak Sealant with standard surgical closureProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.	Device	ProGEL Pleural Air Leak Sealant with standard surgical closure
ProGEL Pleural Air Leak Sealant without standard surgical closureProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.	Device	ProGEL Pleural Air Leak Sealant without standard surgical closure

Primary outcome

Safety Endpoints
Time frame: 90 days
* Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome * Renal adverse events * Cardiac adverse events * Death (all causes) * Hospital readmission

Results and safety

Results posted to the registry on 11 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	168	147
ProGEL Pleural Air Leak Sealant	276	245

Primary outcome: Safety Endpoints

Time frame: 90 days. Count of units. Unit: Events

Measure	Control n = 168	ProGEL Pleural Air Leak Sealant n = 276
Pneumothorax	22	48
Persistent air leak	25	40
Late onset air leak	1	6
Residual pleural space	1	1
Acute respiratory distress syndrome	1	3
Renal abnormalities	5	7
Myocardial Infarction	0	2
Atrial Arrythmia	29	48

Population analysed: Units analyzed represents the number of adverse events that occurred among all study participants in each arm. Also, the original Protocol was designed to study ProGel (any usage) versus no ProGel. After the study was completed, the FDA requested that the ProGel group be broken out by patients with standard closure, and without.

Adverse events

Time frame: 90 days post-index procedure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	40 of 168 (23.8%)	39 of 168 (23.2%)	6 of 168
ProGEL Pleural Air Leak Sealant With Standard Surgical Closure	37 of 169 (21.9%)	52 of 169 (30.8%)	5 of 169
ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure	27 of 107 (25.2%)	33 of 107 (30.8%)	2 of 107

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

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.

Robert J. Cerfolio, MD principal investigator

University of Alabama in Birmingham

Daniel L. Miller, MD principal investigator

WellStar Research Institute

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 5 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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 Jul 2017). 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?

Safety Endpoints (time frame: 90 days). 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 NCT01394978.

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 15 Jul 2021.