Pulmonary EmphysemaNCT01520064
Post Market Registry Study of the AeriSeal System
An observational study of Pulmonary Emphysema, run by Aeris Therapeutics at 12 sites in 2 countries.
Trial summary
Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting; Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Emphysema
- How many people
- 25 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Feb 2012to Nov 2013
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients must have been or will be treated with the AeriSeal System
Who may be able to join
- Advanced Emphysema
- AeriSeal System treatment
Who cannot join
- have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
- have had frequent COPD exacerbations within the past year
- require mechanical ventilatory support
- have a pretreatment DLCO < 20% predicted or > 60% predicted
- have a pretreatment FEV1 < 20% predicted AND homogeneous emphysema
- have giant bullae
Show all 9Show fewer
- have undergone lung transplantation, lung volume reduction surgery, or lobectomy
- are intolerant of corticosteroids or antibiotics
- are pregnant or breast-feeding
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Germany10 sites
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Klinikum Coburg
Coburg, 96450
Klinikum Donaustauf
Donaustauf, 93093
Asklepios Fachkliniken Muenchen-Gauting
Gauting, 82131
Universitatsklinikum Halle
Halle, 06120
Asklepios Klinik Hamburg-Harburg
Hamburg, 21075
Thoraxklinik am Uniklinikum Heidelberg
Heidelberg, D-69126
Sana Kliniken Luebeck
Lübeck, 23560
Klinikum Nuerberg Nord
Nuremberg, 90419
Bethanien KH Solingen
Solingen, 42699
Israel2 sites
Soroka Medical Center
Beer Sheeva, 84101
Rabin Medical Center, Beilinson Campus
Petach Tikvah, 49100
About this study
- Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
- Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.
- Conditions
- Pulmonary Emphysema
- Keywords
- Emphysema, GOLD Stage III, GOLD Stage IV, AeriSeal System, Homogeneous, Heterogeneous, Upper Lobe Predominant, ULP, Chronic Obstructive Pulmonary Disease, COPD, Lung Volume Reduction Surgery, LVRS, Bronchoscopic Lung Volume Reduction, BLVR
- Medical subject headings
- Pulmonary Emphysema, Emphysema, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Market Registry Study of the AeriSeal System
-Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-martet setting
Measured: At least 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmphysemaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Aeris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janine McDermott, MS CCRP, Study director, Aeris Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520064
- Sponsor's protocol ID
- 03-C12-001PLV
- Status last verified
- Nov 2013
- First submitted
- 25 Jan 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Registry Study of the AeriSeal System
- ClinicalTrials.gov ID
- NCT01520064
- Acronym / sponsor ID
- 03-C12-001PLV
- Conditions
- Pulmonary Emphysema
- Keywords
- Emphysema, GOLD Stage III, GOLD Stage IV, AeriSeal System, Homogeneous, Heterogeneous, Upper Lobe Predominant, ULP
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Aeris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Jan 2012 (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.
- Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
- Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must have been or will be treated with the AeriSeal System
Key inclusion criteria (2 listed)
- Advanced Emphysema
- AeriSeal System treatment
Key exclusion criteria (9 listed)
- have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
- have had frequent COPD exacerbations within the past year
- require mechanical ventilatory support
- have a pretreatment DLCO < 20% predicted or > 60% predicted
- have a pretreatment FEV1 < 20% predicted AND homogeneous emphysema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post Market Registry Study of the AeriSeal System
Time frame: At least 4 years
-Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-martet setting
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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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.
Janine McDermott, MS CCRP study director
Aeris Therapeutics
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Emphysema, run by Aeris Therapeutics at 12 sites in 2 countries.
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 9 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: stopped early, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Israel. 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 was stopped early. Results are not available in the source record.
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?
Post Market Registry Study of the AeriSeal System (time frame: At least 4 years). 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 14 Nov 2013.