Non-Small Cell Lung CancerE-SEALNCT07479277
Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC
A study testing Progel Platinum and Mechanical Stapling in people with Non-Small Cell Lung Cancer and Postoperative Air Leak, run by Fondazione del Piemonte per l'Oncologia at 6 sites in Italy.
Trial summary
This multicenter randomized trial evaluates whether routine use of Progel Platinum surgical sealant on stapled fissure lines during VATS upper or lower lobectomy for NSCLC reduces pleural drainage duration compared with standard stapling alone. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Postoperative Air Leak, NSCLC
- What is being tested?
- Progel Platinum and Mechanical Stapling
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 6 sitesItaly
- Study dates
- 27 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Written informed consent
- Planned VATS upper or lower lobectomy for NSCLC
- Minimally invasive thoracoscopic approach
- Middle lobectomy excluded
Who cannot join
- Induction radiochemotherapy or chemo-immunotherapy
- Severe COPD: GOLD 3 or higher
- Sleeve resection or extended resection involving other lobes/chest wall/pericardium, etc.
- Albumin intolerance/allergy
- Renal insufficiency
- Redo surgery
- Use of sealants/adhesives other than the study approach
- Expected extensive pleural adhesions
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Not yet recruiting
Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare
Bolzano
Francesco Zaraca
- Recruiting
Unità di Chirurgia Toracica Oncologica
Candiolo, Torino, 10060
Andrea Droghetti, MD, +390119933850, andrea.droghetti@ircc.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence
Alessandro Gonfiotti
- Not yet recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
Mario Nosotti
- Not yet recruiting
Irccs Ismett
Palermo
Alessandro Bertani
- Not yet recruiting
Azienda Ospedaliera-Universitaria Pisana
Pisa
Marcello Carlo Ambrogi
About this study
Official title: A Multicenter, Randomized, Parallel-Group Trial Evaluating Progel Platinum Added to Mechanical Stapling Versus Mechanical Stapling Alone in Patients Undergoing VATS Upper or Lower Lobectomy for Non-Small Cell Lung Cancer
This multicenter randomized trial evaluates whether routine use of Progel Platinum surgical sealant on stapled fissure lines during VATS upper or lower lobectomy for NSCLC reduces pleural drainage duration compared with standard stapling alone. Secondary objectives include postoperative length of stay, incidence and duration of postoperative air leaks, residual pleural space, safety outcomes, and hospitalization costs.
Read the detailed description
Lobectomy is the standard surgical treatment for many patients with early-stage NSCLC, but postoperative air leak remains a frequent complication associated with prolonged chest tube duration, longer hospitalization, and increased healthcare costs. Preliminary non-randomized evidence suggests that Progel Platinum may improve intraoperative sealing of fissure lines and reduce postoperative air leaks. E-SEAL is a prospective, randomized, controlled, multicenter study in 8 thoracic surgery centers. Eligible adult patients undergoing minimally invasive VATS upper or lower lobectomy for NSCLC are randomized 1:1 to stapling alone or stapling plus Progel Platinum. The primary endpoint is pleural drainage duration in hours. Secondary endpoints include postoperative length of stay, hospitalization costs, postoperative air leak incidence and volume, residual pleural space, complications, re-interventions, and follow-up outcomes up to 60 days after surgery/discharge.
- Conditions
- Non-Small Cell Lung Cancer, Postoperative Air Leak, NSCLC
- Being tested
- Progel Platinum, Mechanical Stapling
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, VATS Lobectomy, Postoperative air leak, Pleural drainage, Progel Platinum, Surgical sealant, Thoracic surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progel PlatinumDevice
Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy
Mechanical StaplingProcedure or surgery
Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.
| Study group | Role | What they receive |
|---|---|---|
| Progel Group (PG) | Experimental | Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line. Receives: Device: Progel Platinum |
| Standard Treatment Group (ST) | Active comparator | Fissure completion with mechanical staplers alone, according to current standard practice. Receives: Procedure: Mechanical Stapling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of pleural drainage
Time from surgery to chest tube removal, measured in hours.
Measured: From surgery to chest tube removal, assessed up to 30 days after surgery
Secondary outcomes (8)
Postoperative hospital length of stay
Time from surgery to hospital discharge, measured in days.
Measured: From surgery to hospital discharge, assessed up to 30 days after surgery
Incidence and volume of postoperative air leaks
Proportion of patients with at least one documented postoperative air leak and mean daily and total postoperative air leak volume, as recorded by the digital drainage system.
Measured: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Incidence of residual pleural space
Proportion of patients with residual pleural space detected on chest imaging during postoperative hospitalization or at follow-up assessment.
Measured: During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge
Postoperative safety outcomes
Incidence of postoperative adverse events and complications, including thoracentesis, new chest drainage, hospital readmission, and re-intervention.
Measured: During postoperative hospitalization and up to 30 days after surgery
Duration of postoperative air leak
Time from surgery to resolution of postoperative air leak, measured in hours.
Measured: From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery
Duration of surgical procedure
Total duration of the surgical procedure, measured in minutes.
Measured: During the surgical procedure
Mean daily and total postoperative air leak volume
Mean daily postoperative air leak volume and cumulative total postoperative air leak volume, measured in liters using the digital drainage system.
Measured: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Air leak indices corrected for length of dissected pulmonary parenchyma
Quantitative postoperative air leak measures adjusted for the length of dissected pulmonary parenchyma to standardize comparisons between patients.
Measured: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start27 Feb 2026
- Primary completion27 Feb 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing VATS upper or lower lobectomy for NSCLC are randomized 1:1 intraoperatively to either standard fissure completion with mechanical staplers alone (control group) or mechanical staplers plus Progel Platinum sealant (experimental group). The study is multicenter and will be conducted in 8 thoracic surgery centers.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479277
- Sponsor's protocol ID
- 001-FPO26
- Acronym
- E-SEAL
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-Group Trial Evaluating Progel Platinum Added to Mechanical Stapling Versus Mechanical Stapling Alone in Patients Undergoing VATS Upper or Lower Lobectomy for Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07479277
- Acronym / sponsor ID
- E-SEAL / 001-FPO26
- Conditions
- Non-Small Cell Lung Cancer, Postoperative Air Leak, NSCLC
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, VATS Lobectomy, Postoperative air leak, Pleural drainage, Progel Platinum, Surgical sealant, Thoracic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter randomized trial evaluates whether routine use of Progel Platinum surgical sealant on stapled fissure lines during VATS upper or lower lobectomy for NSCLC reduces pleural drainage duration compared with standard stapling alone. Secondary objectives include postoperative length of stay, incidence and duration of postoperative air leaks, residual pleural space, safety outcomes, and hospitalization costs.
Detailed description
Lobectomy is the standard surgical treatment for many patients with early-stage NSCLC, but postoperative air leak remains a frequent complication associated with prolonged chest tube duration, longer hospitalization, and increased healthcare costs. Preliminary non-randomized evidence suggests that Progel Platinum may improve intraoperative sealing of fissure lines and reduce postoperative air leaks. E-SEAL is a prospective, randomized, controlled, multicenter study in 8 thoracic surgery centers. Eligible adult patients undergoing minimally invasive VATS upper or lower lobectomy for NSCLC are randomized 1:1 to stapling alone or stapling plus Progel Platinum. The primary endpoint is pleural drainage duration in hours. Secondary endpoints include postoperative length of stay, hospitalization costs, postoperative air leak incidence and volume, residual pleural space, complications, re-interventions, and follow-up outcomes up to 60 days after surgery/discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients undergoing VATS upper or lower lobectomy for NSCLC are randomized 1:1 intraoperatively to either standard fissure completion with mechanical staplers alone (control group) or mechanical staplers plus Progel Platinum sealant (experimental group). The study is multicenter and will be conducted in 8 thoracic surgery centers.
| Arm | Type | Receives |
|---|---|---|
| Progel Group (PG) | Experimental | Device: Progel PlatinumFissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line. |
| Standard Treatment Group (ST) | Active comparator | Procedure: Mechanical StaplingFissure completion with mechanical staplers alone, according to current standard practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Written informed consent
- Planned VATS upper or lower lobectomy for NSCLC
- Minimally invasive thoracoscopic approach
- Middle lobectomy excluded
Key exclusion criteria (8 listed)
- Induction radiochemotherapy or chemo-immunotherapy
- Severe COPD: GOLD 3 or higher
- Sleeve resection or extended resection involving other lobes/chest wall/pericardium, etc.
- Albumin intolerance/allergy
- Renal insufficiency
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 PlatinumProgel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy | Device | Progel Group (PG) |
| Mechanical StaplingStandard mechanical stapling used for fissure completion during VATS upper or lower lobectomy. | Procedure or surgery | Standard Treatment Group (ST) |
Primary outcome
Duration of pleural drainage
Time frame: From surgery to chest tube removal, assessed up to 30 days after surgery
Time from surgery to chest tube removal, measured in hours.
8 secondary outcomes
Postoperative hospital length of stay
Time frame: From surgery to hospital discharge, assessed up to 30 days after surgery
Incidence and volume of postoperative air leaks
Time frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Incidence of residual pleural space
Time frame: During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge
Postoperative safety outcomes
Time frame: During postoperative hospitalization and up to 30 days after surgery
Duration of postoperative air leak
Time frame: From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery
Duration of surgical procedure
Time frame: During the surgical procedure
Mean daily and total postoperative air leak volume
Time frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Air leak indices corrected for length of dissected pulmonary parenchyma
Time frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progel Platinum and Mechanical Stapling in people with Non-Small Cell Lung Cancer and Postoperative Air Leak, run by Fondazione del Piemonte per l'Oncologia at 6 sites in Italy.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Droghetti MD (00390119933850, andrea.droghetti@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of pleural drainage (time frame: From surgery to chest tube removal, assessed up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.