Lung SurgeryTENATACNCT06597604
Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
A study testing Intraoperative use of TenaTac in lung surgery and Intraoperative use of usual sealant in lung surgery in people with Lung Surgery, run by Hopitaux Prives de Metz, Groupe UNEOS at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Surgery
- What is being tested?
- Intraoperative use of TenaTac in lung surgery and Intraoperative use of usual sealant in lung surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Centre Hospitalier de la Côte Basque (Bayonne)
Bayonne, 64100
Caroline RIVERA, MD, +33559443502 ext. +33, crivera@ch-cotebasque.fr
Caroline RIVERA, MD
Hôpital Robert Schuman_Groupe UNEOS
Metz, Grand Est, 57000
Sofiane Saada, PhD, +33357843376 ext. +33, sofiane.saada@uneos.fr
Alessandro ORSINI, MD
About this study
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.
Read the 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
- Being tested
- Intraoperative use of TenaTac in lung surgery, Intraoperative use of usual sealant in lung surgery
- Keywords
- Lung surgery, TenaTac, Gelatin Patch, Sealant, PAL, Pulmonary Air Leak, Lobectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative use of TenaTac in lung surgeryDevice
Use of innovative medical device : TenaTac
Intraoperative use of usual sealant in lung surgeryDevice
Use of the usual scealant as a control
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Thoracic Surgeons will apply the experimental device TenaTac® after major lung resection Receives: Device: Intraoperative use of TenaTac in lung surgery |
| Control Group | Active comparator | Thoracic Surgeons will apply other (usual) sealing device after major lung resection Receives: Device: Intraoperative use of usual sealant in lung surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Assess the effectiveness of the TenaTac® patch in terms of duration of thoracic drainage, compared with sealing devices routinely used by thoracic surgeons for the same indication.
Measured: 4 weeks
Secondary outcomes (3)
To assess the effectiveness of the TenaTac® patch in preventing postoperative air leaks throughout the hospital stay, and more specifically in PALs (beyond the 5th day).
Assess the effectiveness of the TenaTac® patch in terms of PAL rates decrease compared to those measured with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances
Measured: 4 weeks
Effectiveness of the TenaTac® patch in reducing hospital stay
Assess the effectiveness of the TenaTac® patch in reducing hospital stay, compared to those obtained with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances
Measured: 4 weeks
Effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications
Assess the effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications, compared to those declared with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopitaux Prives de Metz, Groupe UNEOS
- Sponsor type
- University, hospital or other
- Collaborators
- CuraMedrix B.V., Medical Advices Consulting
- Responsible party
- Sponsor
- Investigators
- Alessandro ORSINI, MD, Principal investigator, Hôpitaux Privés de Metz, Groupe UNEOS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597604
- Sponsor's protocol ID
- PI-2024-002
- Other IDs
- 2024-A01716-41
- Acronym
- TENATAC
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected throughout the trial used in the results publication will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT06597604
- Acronym / sponsor ID
- TENATAC / PI-2024-002
- Conditions
- Lung Surgery
- Keywords
- Lung surgery, TenaTac, Gelatin Patch, Sealant, PAL, Pulmonary Air Leak, Lobectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Hopitaux Prives de Metz, Groupe UNEOSUniversity, hospital or other
- Collaborators
- CuraMedrix B.V., Medical Advices Consulting
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Intraoperative use of TenaTac in lung surgeryThoracic Surgeons will apply the experimental device TenaTac® after major lung resection |
| Control Group | Active comparator | Device: Intraoperative use of usual sealant in lung surgeryThoracic Surgeons will apply other (usual) sealing device after major lung resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative use of TenaTac in lung surgeryUse of innovative medical device : TenaTac | Device | Experimental Group |
| Intraoperative use of usual sealant in lung surgeryUse of the usual scealant as a control | Device | Control Group |
Primary outcome
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
Time frame: 4 weeks
Assess the effectiveness of the TenaTac® patch in terms of duration of thoracic drainage, compared with sealing devices routinely used by thoracic surgeons for the same indication.
3 secondary outcomes
To assess the effectiveness of the TenaTac® patch in preventing postoperative air leaks throughout the hospital stay, and more specifically in PALs (beyond the 5th day).
Time frame: 4 weeks
Effectiveness of the TenaTac® patch in reducing hospital stay
Time frame: 4 weeks
Effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes. Data collected throughout the trial used in the results publication will be shared with other researchers
Related trials for Lung Surgery
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruiting
Individualized Inspired Oxygen Fraction Titration During Lung Surgery (iOXY-LUNG)
Postoperative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro ORSINI, MD principal investigator
Hôpitaux Privés de Metz, Groupe UNEOS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative use of TenaTac in lung surgery and Intraoperative use of usual sealant in lung surgery in people with Lung Surgery, run by Hopitaux Prives de Metz, Groupe UNEOS at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofiane Saada, PhD (+33357843376 ext. +33, sofiane.saada@uneos.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.