Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery

NCT ID: NCT06597604

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-06-30

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- 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.

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 based on 2 surgical techniques: open (by posterolateral thoracotomy) or minimally invasive endoscopic (with or without robot-assisted surgery).

Lobectomy is the most common pulmonary resection, however, regardless of the surgical option chosen, 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, pulmonary alveolar collapse, acute respiratory distress syndrome, pleural or pericardial effusion, lobar torsion or multi-organ failure, bronchial or esophageal fistulas, transient arrhythmia due to vagus nerve damage, pulmonary embolism, venous ischemia, ... and, per- and post-operative air leaks. Air leak has been reported in 25-75% of patients, which makes it the most common incident after elective lung surgery.

Although the majority of these air leaks resolve spontaneously within 48 hours (by continuous pleural drainage), certain cases persist for several days (more than 5 days). These are known as prolonged air leaks, or PAL.

The literature describes several sealing agents used to contain air leaks. The preventive use of sealants at the lung resection site seems safe and effective, since it significantly reduces the intensity and incidence of postoperative air leaks, and the time required for drain removal, Pharmaceutical gelatin-based medical devices, used for decades for their hemostatic properties, have recently been suggested for sealing pulmonary defects and preventing air leaks. Regarding the results obtained, gelatin appears to be a therapeutically effective biomaterial in lung surgery. We therefore hypothesize the effectiveness of the innovative medical device TenaTac® (Selentus Science, UK) in preventing air leak after major lung resection.

Conditions

Lung Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Thoracic Surgeons will apply the experimental device TenaTac® after major lung resection

Group Type: EXPERIMENTAL

Intraoperative use of TenaTac in lung surgery

Intervention Type: DEVICE

Use of innovative medical device : TenaTac

Control Group

Thoracic Surgeons will apply other (usual) sealing device after major lung resection

Group Type: ACTIVE_COMPARATOR

Intraoperative use of usual sealant in lung surgery

Intervention Type: DEVICE

Use of the usual scealant as a control

Interventions

Intraoperative use of TenaTac in lung surgery

Use of innovative medical device : TenaTac

Intervention Type: DEVICE

Intraoperative use of usual sealant in lung surgery

Use of the usual scealant as a control

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CuraMedrix B.V.

UNKNOWN

Sponsor Role: collaborator

Medical Advices Consulting

UNKNOWN

Sponsor Role: collaborator

Hopitaux Prives de Metz, Groupe UNEOS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro ORSINI, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Privés de Metz, Groupe UNEOS

Locations

Hôpital Robert Schuman_Groupe UNEOS

Metz, Grand Est, France

Centre Hospitalier de la Côte Basque (Bayonne)

Bayonne, , France

Countries

France

Central Contacts

Sofiane Saada, PhD

Role: CONTACT

sofiane.saada@uneos.fr

+33357843376 ext. +33

Alessandro ORSINI, MD

Role: CONTACT

alessandro.orsini@uneos.fr

+33357842227 ext. +33

Facility Contacts

Sofiane Saada, PhD

Role: primary

sofiane.saada@uneos.fr

+33357843376 ext. +33

Caroline RIVERA, MD

Role: primary

crivera@ch-cotebasque.fr

+33559443502 ext. +33

Other Identifiers

2024-A01716-41

Identifier Type: OTHER

Identifier Source: secondary_id

PI-2024-002

Identifier Type: -

Identifier Source: org_study_id