CompletedPhase 4

SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

Spain170 participantsStarted 2016-03

Plain-language summary

The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques. Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients over the age of 18 years who are able to give their informed consent * Patients undergoing lung resection surgery for either malignant or benign conditions including: * Lobar and sublobar resections * Open, video-assisted thoracoscopic or robotic surgeries * Diagnostic or therapeutic procedures Exclusion Criteria: * Traumatic pulmonary contusion or laceration * Lung reduction surgery * Planned removal of more than 10 lung lesions * Pneumonectomy * Known hypersensitivity to bovine protein * Known hypersensitivity to Brilliant Blue FCF (E133) * Presence of active infection

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of postoperative air leaks

Timeframe: Within first 30 postoperative days

Trial details

NCT IDNCT02668978

SponsorQuirón Madrid University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-31

View on ClinicalTrials.gov More LUNG DISEASES trials