Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thorac… (NCT06597604) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
France154 participantsStarted 2025-03-01
Plain-language summary
Lung surgery remains a high-risk procedure, with serious adverse events that can occur later, including postoperative bleeding or hemothorax, pneumopathy or surgical site infection but also ... per- and post-operative air leaks. Majority the air leaks resolve spontaneously within 48 hours but certain cases persist within several days which known as prolonged air leaks, or PAL. Several safe and effective sealing agents are used to contain and or reduce the intensity and incidence of postoperative air leaks, and the time required for drain removal. This protocol assesses the effectiveness of an innovative gelatin-based medical device named TenaTac® (Selentus Science, UK) in preventing air leak after major lung resection.
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 hospitalized in the thoracic surgery departments of the investigating centers, for elective surgery,
* Lobectomy surgery requiring the use of a sealing agent,
* Adult patients (\>18 years),
* Patients who have given written consent to participate in the study,
* Patients registered within the social security insurance in France.
Exclusion Criteria:
* Patients hospitalized in emergency,
* Patients with gelatin allergy,
* Patients undergoing other biomedical research likely to interfere with the evaluation criteria of this study
* Patients under tutorship and/or curatorship,
* Patients unable to follow the planned post-operative follow-up,
* Patients whose life expectancy is less than 1 year,
* Pregnant or breast-feeding patients.
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
1
To compare the effectiveness of the TenaTac® patch on the duration of thoracic drainage for each patient (regardless of their degree of emphysema) compared to sealing devices routinely used by thoracic surgeons for the same indication