EmphysemaNCT02996149
Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure
An observational study of Emphysema, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- Endoscopic lung volume reduction coil treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe emphysema and chronic hypercapnic respiratory failure, in whom endoscopic lung volume reduction coil treatment is performed
Who may be able to join
- Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) < 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed
- Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg)
- Informed consent
Who cannot join
- Therapeutic anticoagulation
- Anti-platelet therapy exceeding the use of acetylsalicylic acid
- Severe pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.
- Conditions
- Emphysema
- Being tested
- Endoscopic lung volume reduction coil treatment
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic lung volume reduction coil treatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PaCO2
Measured: 3 months after endoscopic lung volume reduction (ELVR)
Secondary outcomes (7)
Changes in PaCO2
Measured: 6 and 12 months after ELVR
Changes in FEV1
Measured: 3, 6 and 12 months after ELVR
Changes in vital capacity
Measured: 3, 6 and 12 months after ELVR
Changes in residual volume
Measured: 3, 6 and 12 months after ELVR
Changes in 6-minute walk distance
Measured: 3, 6 and 12 months after ELVR
Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ)
Measured: 3, 6 and 12 months after ELVR
Changes in BMI
Measured: 3, 6 and 12 months after ELVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: Technique no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hans Klose, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996149
- Sponsor's protocol ID
- PV-5379
- Status last verified
- Dec 2019
- First submitted
- 16 Nov 2016
- Last updated
- 24 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT02996149
- Acronym / sponsor ID
- PV-5379
- Conditions
- Emphysema
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Technique no longer available
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 19 Dec 2016 (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.
Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe emphysema and chronic hypercapnic respiratory failure, in whom endoscopic lung volume reduction coil treatment is performed
Key inclusion criteria (3 listed)
- Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) < 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed
- Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg)
- Informed consent
Key exclusion criteria (3 listed)
- Therapeutic anticoagulation
- Anti-platelet therapy exceeding the use of acetylsalicylic acid
- Severe pulmonary hypertension
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 |
|---|---|---|
| Endoscopic lung volume reduction coil treatment | Procedure or surgery | – |
Primary outcome
Changes in PaCO2
Time frame: 3 months after endoscopic lung volume reduction (ELVR)
7 secondary outcomes
Changes in PaCO2
Time frame: 6 and 12 months after ELVR
Changes in FEV1
Time frame: 3, 6 and 12 months after ELVR
Changes in vital capacity
Time frame: 3, 6 and 12 months after ELVR
Changes in residual volume
Time frame: 3, 6 and 12 months after ELVR
Changes in 6-minute walk distance
Time frame: 3, 6 and 12 months after ELVR
Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ)
Time frame: 3, 6 and 12 months after ELVR
Changes in BMI
Time frame: 3, 6 and 12 months after ELVR
Results and safety
The study was stopped early (reason given: Technique no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emphysema, run by Universitätsklinikum Hamburg-Eppendorf 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 3 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: stopped early, as of the sponsor's last update on 24 Dec 2019. 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.
Are results available for this study?
The study was stopped early (reason given: Technique no longer available). 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?
Changes in PaCO2 (time frame: 3 months after endoscopic lung volume reduction (ELVR)). 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 24 Dec 2019.