RecruitingNot ApplicableNCT07479277

Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC

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


Sponsor

Fondazione del Piemonte per l'Oncologia

Enrollment

160 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

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. Secondary objectives include postoperative length of stay, incidence and duration of postoperative air leaks, residual pleural space, safety outcomes, and hospitalization costs.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a sealant product called Progel Platinum to see if it can reduce air leaks after minimally invasive lung surgery (video-assisted thoracoscopic surgery, or VATS) to remove a lobe of the lung in patients with non-small cell lung cancer. Air leaks after lung surgery are a common complication that prolongs hospital stays. **You may be eligible if...** - You are 18 or older - You are scheduled for minimally invasive (VATS) removal of an upper or lower lung lobe for non-small cell lung cancer - You have given written informed consent **You may NOT be eligible if...** - You received chemotherapy, immunotherapy, or radiation before your surgery - You have severe COPD (GOLD stage 3 or higher) - You have an allergy or intolerance to albumin (a protein used in the sealant) - You have kidney problems - You are having a more extensive surgery (e.g., involving the chest wall or heart lining) - You have had prior lung surgery (redo surgery) - You are expected to have extensive scar tissue in the chest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEProgel Platinum

Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy

PROCEDUREMechanical Stapling

Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.


Locations(6)

Unità di Chirurgia Toracica Oncologica

Candiolo, Torino, Italy

Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare

Bolzano, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Italy

Irccs Ismett

Palermo, Italy

Azienda Ospedaliera-Universitaria Pisana

Pisa, Italy

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NCT07479277


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