Status:
NOT_YET_RECRUITING
Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
Lead Sponsor:
Hopitaux Prives de Metz, Groupe UNEOS
Collaborating Sponsors:
CuraMedrix B.V.
Medical Advices Consulting
Conditions:
Lung Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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- a...
Detailed Description
Thoracic surgery is a specialty dedicated to the management (diagnosis and treatment...) of conditions and lesions of the thoracic cage and its organs, excluding the heart, aorta and esophagus. It is ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06597604
Start Date
March 1 2025
End Date
June 30 2026
Last Update
February 3 2025
Active Locations (2)
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1
Hôpital Robert Schuman_Groupe UNEOS
Metz, Grand Est, France, 57000
2
Centre Hospitalier de la Côte Basque (Bayonne)
Bayonne, France, 64100