Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC (E-SEAL)

March 16, 2026 updated by: Fondazione del Piemonte per l'Oncologia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Bolzano, Italy
        • Not yet recruiting
        • Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare
        • Contact:
          • Francesco Zaraca
      • Florence, Italy
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Careggi
        • Contact:
          • Alessandro Gonfiotti
      • Milan, Italy
        • Not yet recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
        • Contact:
          • Mario Nosotti
      • Palermo, Italy
        • Not yet recruiting
        • Irccs Ismett
        • Contact:
          • Alessandro Bertani
      • Pisa, Italy
        • Not yet recruiting
        • Azienda Ospedaliera-Universitaria Pisana
        • Contact:
          • Marcello Carlo Ambrogi
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Unità di Chirurgia Toracica Oncologica
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Written informed consent
  • Planned VATS upper or lower lobectomy for NSCLC
  • Minimally invasive thoracoscopic approach
  • Middle lobectomy excluded

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Progel Group (PG)
Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line.
Device: Progel Platinum
Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy
Active Comparator: Standard Treatment Group (ST)
Fissure completion with mechanical staplers alone, according to current standard practice.
Procedure: Mechanical Stapling
Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From surgery to chest tube removal, assessed up to 30 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative hospital length of stay
Time Frame: From surgery to hospital discharge, assessed up to 30 days after surgery
Time from surgery to hospital discharge, measured in days.
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
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.
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
Proportion of patients with residual pleural space detected on chest imaging during postoperative hospitalization or at follow-up assessment.
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
Incidence of postoperative adverse events and complications, including thoracentesis, new chest drainage, hospital readmission, and re-intervention.
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
Time from surgery to resolution of postoperative air leak, measured in hours.
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
Total duration of the surgical procedure, measured in minutes.
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
Mean daily postoperative air leak volume and cumulative total postoperative air leak volume, measured in liters using the digital drainage system.
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
Quantitative postoperative air leak measures adjusted for the length of dissected pulmonary parenchyma to standardize comparisons between patients.
Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione del Piemonte per l'Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001-FPO26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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