Heterogeneous EmphysemaPhase 1/2NCT00684892
Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
A Phase 1/2 study testing Chartis System in people with Heterogeneous Emphysema, run by Pulmonx Corporation at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heterogeneous Emphysema
- What is being tested?
- Chartis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Nov 2008
- Phase
- Phase 1/2
- 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
- Heterogeneous emphysema as determined by high-resolution CT scan
- Scheduled for clinically indicated ELVR procedure
Who cannot join
- Hyperexcretive chronic bronchitis or excessive sputum secretion
- Active pulmonary infection
- Active asthma or lung hyper-responsiveness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Thoraxklinik am Universitatsklinikum Heidelberg
Heidelberg, D-69126
About this study
Official title: A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).
- Conditions
- Heterogeneous Emphysema
- Being tested
- Chartis System
- Keywords
- Emphysema, Endobronchial Lung Volume Reduction
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chartis SystemDevice
Assessment of airway flow and pressure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Chartis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Until end of study procedure
Secondary outcomes (1)
Technical success
Measured: During procedure and up 1 week post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterogeneous 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmonx Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Felix Herth, MD, Principal investigator, Thoraxklinik am Universitatsklinikum Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684892
- Sponsor's protocol ID
- PRT01029
- Status last verified
- Jan 2009
- First submitted
- 23 May 2008
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
- ClinicalTrials.gov ID
- NCT00684892
- Acronym / sponsor ID
- PRT01029
- Conditions
- Heterogeneous Emphysema
- Keywords
- Emphysema, Endobronchial Lung Volume Reduction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Pulmonx CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 May 2008 (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.
The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Chartis System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heterogeneous emphysema as determined by high-resolution CT scan
- Scheduled for clinically indicated ELVR procedure
Key exclusion criteria (3 listed)
- Hyperexcretive chronic bronchitis or excessive sputum secretion
- Active pulmonary infection
- Active asthma or lung hyper-responsiveness
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 |
|---|---|---|
| Chartis SystemAssessment of airway flow and pressure | Device | 1 |
Primary outcome
Adverse events
Time frame: Until end of study procedure
1 secondary outcome
Technical success
Time frame: During procedure and up 1 week post procedure
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 22 Jan 2009.
Related trials for Heterogeneous Emphysema
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.
Felix Herth, MD principal investigator
Thoraxklinik am Universitatsklinikum Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chartis System in people with Heterogeneous Emphysema, run by Pulmonx Corporation at 1 site in Germany.
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 3 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 22 Jan 2009. 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 Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adverse events (time frame: Until end of study procedure). 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 22 Jan 2009.