Malignant Neoplasm of LungNCT01451359
Endobronchial Valves in Persistent Air Leak
A study testing EndoBronchial Valve in people with Malignant Neoplasm of Lung, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Because an endobronchial valve is a one-way inspiratory airway blocker, it is hypothesized that it could be also used for controlling persistent air leaks while maintaining the drainage of secretions. The U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Lung
- What is being tested?
- EndoBronchial Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2011to Oct 2013
- 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
- Prolonged (≥10 days postoperative) persistent air leak refractory to conventional treatments (such as prolonged drainage and/or chemical pleurodesis).
- Anatomical lung resection such as segmentectomy, (bi)lobectomy or sleeve lobectomy.
- Air leak after antero/posterolateral thoracotomy or video-assisted thoracoscopy (VATS).
- Type of air leak : expiratory.
- Size of air leak : any.
Who cannot join
- Prolonged air leak <10 days postoperative.
- Pneumonectomy or none-anatomical lung resection.
- Lung resection for another indication than cancer.
- Previous reintervention or previous Heimlich valve for this air leak.
- Empyema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Endobronchial Valves in Persistent Air Leak After Anatomical Pulmonary Resection for Cancer.
Because an endobronchial valve is a one-way inspiratory airway blocker, it is hypothesized that it could be also used for controlling persistent air leaks while maintaining the drainage of secretions. The U.S. Food and Drug Administration approved in October 2008 the Spiration valve system designed to control air leaks in the lung that persist after lung surgery. This prospective observational study aims to evaluate the efficacy and safety of Spiration endobronchial valves in a prospective series of consecutive patients with a prolonged persistent air leak after anatomic surgical resection for cancer.
Read the detailed description
Persistent Air Leak (PAL) is independently associated with prolonged hospital length of stay, decreased patient satisfaction, increased morbidity or postoperative complications, and adds significantly to the cost. The management of air leaks is primarily preventive and therefore starts in the operating room with surgical techniques that can minimize the occurrence of post-operative air leaks, such as the creation of pleural tents or use of suture line glues or sealants. Notwithstanding some patients will after a lung resection have PAL. Any minimal invasive method that helps to increase our ability to treat (reduce and/or stop) the air leak in these latest cases carries an enormous clinical as well as cost-saving potential. Bronchoscopic occlusion of a segmental or subsegmental bronchus using endobronchial valves is such a less invasive method which has shown in case reports to interrupt an air leak.
- Conditions
- Malignant Neoplasm of Lung
- Being tested
- EndoBronchial Valve
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoBronchial ValveDevice
Also called Spiration IBV™ valve system
The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
| Study group | Role | What they receive |
|---|---|---|
| endobronchial valve | Experimental | The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope. Receives: Device: EndoBronchial Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical efficacy
Clinical efficacy on air leak cessation allowing drain(s) removal.
Measured: One month
Secondary outcomes (1)
Safety
- Complications related to endobronchial valve: fever, pulmonary infection, valve migration, pneumothorax requiring treatment.
- Avoidance of ambulatory Heimlich valve and re-operation.
- Timing of drain removal.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
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 Malignant Neoplasm of LungStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrtistophe Dooms, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451359
- Sponsor's protocol ID
- s51545
- Status last verified
- Oct 2011
- First submitted
- 4 Oct 2011
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dooms CA, Decaluwe H, Yserbyt J, De Leyn P, Van Raemdonck D, Ninane V. Bronchial valve treatment for pulmonary air leak after anatomical lung resection for cancer. Eur Respir J. 2014 Apr;43(4):1142-8. doi: 10.1183/09031936.00117613. Epub 2013 Nov 14.
PubMed 24232700
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Endobronchial Valves in Persistent Air Leak After Anatomical Pulmonary Resection for Cancer.
- ClinicalTrials.gov ID
- NCT01451359
- Acronym / sponsor ID
- s51545
- Conditions
- Malignant Neoplasm of Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Oct 2011 (estimated)
- 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.
Because an endobronchial valve is a one-way inspiratory airway blocker, it is hypothesized that it could be also used for controlling persistent air leaks while maintaining the drainage of secretions. The U.S. Food and Drug Administration approved in October 2008 the Spiration valve system designed to control air leaks in the lung that persist after lung surgery. This prospective observational study aims to evaluate the efficacy and safety of Spiration endobronchial valves in a prospective series of consecutive patients with a prolonged persistent air leak after anatomic surgical resection for cancer.
Detailed description
Persistent Air Leak (PAL) is independently associated with prolonged hospital length of stay, decreased patient satisfaction, increased morbidity or postoperative complications, and adds significantly to the cost. The management of air leaks is primarily preventive and therefore starts in the operating room with surgical techniques that can minimize the occurrence of post-operative air leaks, such as the creation of pleural tents or use of suture line glues or sealants. Notwithstanding some patients will after a lung resection have PAL. Any minimal invasive method that helps to increase our ability to treat (reduce and/or stop) the air leak in these latest cases carries an enormous clinical as well as cost-saving potential. Bronchoscopic occlusion of a segmental or subsegmental bronchus using endobronchial valves is such a less invasive method which has shown in case reports to interrupt an air leak.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endobronchial valve | Experimental | Device: EndoBronchial ValveThe implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prolonged (≥10 days postoperative) persistent air leak refractory to conventional treatments (such as prolonged drainage and/or chemical pleurodesis).
- Anatomical lung resection such as segmentectomy, (bi)lobectomy or sleeve lobectomy.
- Air leak after antero/posterolateral thoracotomy or video-assisted thoracoscopy (VATS).
- Type of air leak : expiratory.
- Size of air leak : any.
Key exclusion criteria (5 listed)
- Prolonged air leak <10 days postoperative.
- Pneumonectomy or none-anatomical lung resection.
- Lung resection for another indication than cancer.
- Previous reintervention or previous Heimlich valve for this air leak.
- Empyema
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 |
|---|---|---|
| EndoBronchial ValveAlso: Spiration IBV™ valve systemThe implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope. | Device | endobronchial valve |
Primary outcome
clinical efficacy
Time frame: One month
Clinical efficacy on air leak cessation allowing drain(s) removal.
1 secondary outcome
Safety
Time frame: One month
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 10 Oct 2013.
- Derived from this study: PubMed 24232700Dooms CA, Decaluwe H, Yserbyt J, De Leyn P, Van Raemdonck D, Ninane V. Bronchial valve treatment for pulmonary air leak after anatomical lung resection for cancer. Eur Respir J. 2014 Apr;43(4):1142-8. doi: 10.1183/09031936.00117613. Epub 2013 Nov 14.
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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.
Chrtistophe Dooms, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoBronchial Valve in people with Malignant Neoplasm of Lung, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 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 10 Oct 2013. 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 Belgium. 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?
clinical efficacy (time frame: One month). 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 NCT01451359, 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 10 Oct 2013.