Postoperative Air LeakStaplerNCT05628415
Comparison Between the Non-powered AEON™ Endostapler and Echelon FLEX™ Powered Plus Stapler With Regards to the Closure of Lung Tissue After Lung Resection in the Presence of Severe Lung Emphysema
A study testing Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb) and Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb) in people with Postoperative Air Leak and Lung Resection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Prolonged air leak is reported in up to 60 to 75% of patients after lung operation in the presence of severe lung emphysema. The effect of the non-powered AEONTM Endostapler as compared to the Echelon FlexTM Powered plus stapler on the volume and duration of air leak and on the time to chest drain removal after lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Air Leak, Lung Resection
- What is being tested?
- Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb) and Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Nov 2022to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Informed Consent signed by the subject
- Patients discussed in the interdisciplinary emphysema treatment board and found to have the indication for a LVRS or patients who meet the criteria in agreement with pneumology recommendation for bilateral or unilateral LVRS with pulmonary emphysema (all morphologies including chronic obstructive pulmonary disease (COPD) GOLD III and IV) or patients operated for other Pathology other than lung emphysema requiring lung resection in the presence of severe lung emphysema.
Who cannot join
- non-bullous pulmonary emphysema
- Severely impaired carbon monoxide diffusing capacity (≤ 20% of predicted value, One-second capacity (FEV1) ≤ 20% of predicted value with a homogeneous emphysema morphology
- Patients with severe pulmonary arterial hypertension (mPAP > 35 mmHg) and are symptomatic
- Significant (i.e. clinically relevant and symptomatic) Coronary Arterial Disease (CAD)
- Inability to follow the procedures of the study, e. g. due to language problems, psychological disorders, dementia, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent person
- Current enrolment in another clinical trial studying an experimental treatment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Basel, Department of Thoracic Surgery
Basel, 4031
About this study
Official title: Comparison Between the Non-powered AEON™ Endostapler and Echelon FLEX™ Powered Plus Stapler With Regards to the Closure of Lung Tissue After Lung Resection in the Presence of Severe Lung Emphysema: A Prospective Randomized Single-blinded Monocentric Study
Prolonged air leak is reported in up to 60 to 75% of patients after lung operation in the presence of severe lung emphysema. The effect of the non-powered AEONTM Endostapler as compared to the Echelon FlexTM Powered plus stapler on the volume and duration of air leak and on the time to chest drain removal after lung operation in the presence of severe lung emphysema will be investigated in a randomized, prospective, single-blinded clinical trial.
Read the detailed description
Patients with severe lung emphysema Grad III or IV scheduled for an operation by video-assisted thoracic surgery (VATS) or open method at the Department of Thoracic Surgery at the University Hospital Basel will be pre-screened in terms of inclusion and exclusion criteria. Before the operation, a randomization envelope is opened in the operation room, in which it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. If for example the non-powered AEONTM Endostapler is randomly allocated to the left side, the right side is automatically operated with the Echelon FLEXTM Powered plus Stapler and vice versa. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. On the day of the operation, postoperative air leak will be measured quantitatively in ml per minute immediately, 2h, 4h, 8h, and 12h after skin closure. Starting on the first postoperative day, this is done twice a day at 8 am and 5 pm until the air leak stops or another surgery must be performed. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read by the investigator.
- Conditions
- Postoperative Air Leak, Lung Resection
- Being tested
- Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb), Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)
- Keywords
- severe lung emphysema, AEON™ Endostapler, Echelon FLEX™ Powered plus Stapler, lung-volume-reduction-surgery (LVRS)
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb)Procedure or surgery
Closure of the left and/or right side of the lung after bilateral or unilateral lung-volume-reduction- surgery is performed with the non-powered Aeon™ Endostapler (Lexington medical) 60-mm and 45-mm. At the end of the operation, two 24F apical chest tubes are placed on each side and are systematically set at -10 cm H2O suction via the Medela- Topaz™ system. Air leak will be measured quantitatively in ml per minute by use of a Medela-Topaz™ system. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read.
Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)Procedure or surgery
Closure of the left and/or right side of the lung after bilateral or unilateral lung-volume-reduction- surgery is performed with the Echelon FLEX™ Powered plus Stapler (Ethicon) 60-mm and 45-mm. At the end of the operation, two 24F apical chest tubes are placed on each side and are systematically set at -10 cm H2O suction via the Medela- Topaz™ system. Air leak will be measured quantitatively in ml per minute by use of a Medela-Topaz™ system. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read.
| Study group | Role | What they receive |
|---|---|---|
| Procedure: non-powered AEON™ Endostapler | Active comparator | Bilateral or unilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) or open method with use of the non-powered AEON™ Endostapler for left and/or right side of the lung. By randomization it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. Receives: Procedure: Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb) |
| Procedure: Echelon FLEX™ Powered plus Stapler | Active comparator | Bilateral or unilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) or open method with use of the Echelon FLEX™ Powered plus Stapler for left and/or right side of the lung. By randomization it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. Receives: Procedure: Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval between the end of operation (skin closure) and air leak closure (when the volume is < 30 ml/min measured twice on Medela- Topaz™ drainage system) between the two staplers.
Comparison of the time interval between the end of operation (skin closure) and air leak closure (when the volume is < 30 ml/min measured twice on drainage system) between the two staplers.
Measured: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Change in Volume of air leak
Volume of air leak measured following connection of chest tube drainages until removal of the chest tubes
Measured: End of the operation (0 hours), at 2 hours, 4 hours, 8 hours and 12 hours thereafter and from the first postoperative day, at 8 am and 5 pm daily until removal of the chest tubes (approx. 3 days to a maximum of 7 days)
Secondary outcomes (4)
Number of postoperative air leaks
Number of postoperative air leaks
Measured: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Duration of postoperative air leaks until removal of the chest tubes in days
Duration of postoperative air leaks until removal of the chest tubes in days
Measured: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Postoperative complications graded using the Clavien -Dindo Classification
The Clavien Classification system differentiates in five degrees of severity upon the intention to treat (Grade-I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions up to Grade-V: Death of a patient).
Measured: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Number of resurgeries due to prolonged or profuse air leak
Number of resurgeries due to prolonged or profuse air leak
Measured: From the day of admittance to hospital to the day of discharge (approx. 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start15 Nov 2022
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Air LeakStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized single-blinded monocentric study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Lardinois, Prof. Dr. med., Study director, Department of Thoracic Surgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628415
- Sponsor's protocol ID
- 2022-D0079; kt22Lardinois3
- Acronym
- Stapler
- Status last verified
- Feb 2025
- First submitted
- 15 Nov 2022
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Macharia-Nimietz EF, Mallaev M, Gecas P, Vujic J, Simmen U, Hojski A, Tamm M, Lardinois D. Efficacy of Non-Powered Stapler in Lung Volume Reduction Surgery of Severe Lung Emphysema: A Prospective Randomized Single-Blinded Monocentric Study. Interdiscip Cardiovasc Thorac Surg. 2026 Apr 1;41(4):ivag071. doi: 10.1093/icvts/ivag071.
PubMed 41787969
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Non-powered AEON™ Endostapler and Echelon FLEX™ Powered Plus Stapler With Regards to the Closure of Lung Tissue After Lung Resection in the Presence of Severe Lung Emphysema: A Prospective Randomized Single-blinded Monocentric Study
- ClinicalTrials.gov ID
- NCT05628415
- Acronym / sponsor ID
- Stapler / 2022-D0079; kt22Lardinois3
- Conditions
- Postoperative Air Leak, Lung Resection
- Keywords
- severe lung emphysema, AEON™ Endostapler, Echelon FLEX™ Powered plus Stapler, lung-volume-reduction-surgery (LVRS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 28 Nov 2022 (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.
Prolonged air leak is reported in up to 60 to 75% of patients after lung operation in the presence of severe lung emphysema. The effect of the non-powered AEONTM Endostapler as compared to the Echelon FlexTM Powered plus stapler on the volume and duration of air leak and on the time to chest drain removal after lung operation in the presence of severe lung emphysema will be investigated in a randomized, prospective, single-blinded clinical trial.
Detailed description
Patients with severe lung emphysema Grad III or IV scheduled for an operation by video-assisted thoracic surgery (VATS) or open method at the Department of Thoracic Surgery at the University Hospital Basel will be pre-screened in terms of inclusion and exclusion criteria. Before the operation, a randomization envelope is opened in the operation room, in which it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. If for example the non-powered AEONTM Endostapler is randomly allocated to the left side, the right side is automatically operated with the Echelon FLEXTM Powered plus Stapler and vice versa. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. On the day of the operation, postoperative air leak will be measured quantitatively in ml per minute immediately, 2h, 4h, 8h, and 12h after skin closure. Starting on the first postoperative day, this is done twice a day at 8 am and 5 pm until the air leak stops or another surgery must be performed. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective randomized single-blinded monocentric study
| Arm | Type | Receives |
|---|---|---|
| Procedure: non-powered AEON™ Endostapler | Active comparator | Procedure: Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb)Bilateral or unilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) or open method with use of the non-powered AEON™ Endostapler for left and/or right side of the lung. By randomization it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. |
| Procedure: Echelon FLEX™ Powered plus Stapler | Active comparator | Procedure: Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)Bilateral or unilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) or open method with use of the Echelon FLEX™ Powered plus Stapler for left and/or right side of the lung. By randomization it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed Consent signed by the subject
- Patients discussed in the interdisciplinary emphysema treatment board and found to have the indication for a LVRS or patients who meet the criteria in agreement with pneumology recommendation for bilateral or unilateral LVRS with pulmonary emphysema (all morphologies including chronic obstructive pulmonary disease (COPD) GOLD III and IV) or patients operated for other Pathology other than lung emphysema requiring lung resection in the presence of severe lung emphysema.
Key exclusion criteria (8 listed)
- non-bullous pulmonary emphysema
- Severely impaired carbon monoxide diffusing capacity (≤ 20% of predicted value, One-second capacity (FEV1) ≤ 20% of predicted value with a homogeneous emphysema morphology
- Patients with severe pulmonary arterial hypertension (mPAP > 35 mmHg) and are symptomatic
- Significant (i.e. clinically relevant and symptomatic) Coronary Arterial Disease (CAD)
- Inability to follow the procedures of the study, e. g. due to language problems, psychological disorders, dementia, etc. of the participant
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 |
|---|---|---|
| Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb)Closure of the left and/or right side of the lung after bilateral or unilateral lung-volume-reduction- surgery is performed with the non-powered Aeon™ Endostapler (Lexington medical) 60-mm and 45-mm. At the end of the operation, two 24F apical chest tubes are placed on each side and are systematically set at -10 cm H2O suction via the Medela- Topaz™ system. Air leak will be measured quantitatively in ml per minute by use of a Medela-Topaz™ system. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read. | Procedure or surgery | Procedure: non-powered AEON™ Endostapler |
| Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)Closure of the left and/or right side of the lung after bilateral or unilateral lung-volume-reduction- surgery is performed with the Echelon FLEX™ Powered plus Stapler (Ethicon) 60-mm and 45-mm. At the end of the operation, two 24F apical chest tubes are placed on each side and are systematically set at -10 cm H2O suction via the Medela- Topaz™ system. Air leak will be measured quantitatively in ml per minute by use of a Medela-Topaz™ system. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read. | Procedure or surgery | Procedure: Echelon FLEX™ Powered plus Stapler |
Primary outcome
Time interval between the end of operation (skin closure) and air leak closure (when the volume is < 30 ml/min measured twice on Medela- Topaz™ drainage system) between the two staplers.
Time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Comparison of the time interval between the end of operation (skin closure) and air leak closure (when the volume is < 30 ml/min measured twice on drainage system) between the two staplers.
Change in Volume of air leak
Time frame: End of the operation (0 hours), at 2 hours, 4 hours, 8 hours and 12 hours thereafter and from the first postoperative day, at 8 am and 5 pm daily until removal of the chest tubes (approx. 3 days to a maximum of 7 days)
Volume of air leak measured following connection of chest tube drainages until removal of the chest tubes
4 secondary outcomes
Number of postoperative air leaks
Time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Duration of postoperative air leaks until removal of the chest tubes in days
Time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Postoperative complications graded using the Clavien -Dindo Classification
Time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Number of resurgeries due to prolonged or profuse air leak
Time frame: From the day of admittance to hospital to the day of discharge (approx. 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 41787969Macharia-Nimietz EF, Mallaev M, Gecas P, Vujic J, Simmen U, Hojski A, Tamm M, Lardinois D. Efficacy of Non-Powered Stapler in Lung Volume Reduction Surgery of Severe Lung Emphysema: A Prospective Randomized Single-Blinded Monocentric Study. Interdiscip Cardiovasc Thorac Surg. 2026 Apr 1;41(4):ivag071. doi: 10.1093/icvts/ivag071.
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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. This study is not recruiting at the moment.
Didier Lardinois, Prof. Dr. med. study director
Department of Thoracic Surgery, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb) and Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb) in people with Postoperative Air Leak and Lung Resection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 21 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 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval between the end of operation (skin closure) and air leak closure (when the volume is < 30 ml/min measured twice on Medela- Topaz™ drainage system) between the two staplers. (time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628415, which also lists 1 linked publication.
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 21 Feb 2025.