EmphysemaNCT03008226
Spiration Valve System 9 mm European Post Market Evaluation Study
An observational study of Emphysema, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this observational study is to investigate the efficacy of 9 mm intrabronchial valve treatment in patients with heterogeneous emphysema and to gain further insights and experience on the treatment with this valve size. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emphysema
- What is being tested?
- Implementation of 9 mm intrabronchial valves
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Aug 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with severe airflow obstruction, severe emphysema, significant hyperinflation, and moderate to severe dyspnea . Eligible patients will have severe emphysema in a target lobe with an intact fissure
Who may be able to join
- Patient is older than 40 years in age
- Patient has severe heterogeneous emphysema with moderate to severe dyspnea as defined as an mMRC of 2 or greater.
- The target lobe and ipsilateral lobe will be separated with an intact fissure, as determined by HRCT (> 90% integrity).
- Patient has received standard-of-care medical management and it has been stable for 6 weeks.
- Patient can walk a minimum of 140 meters in the six minute walk test.
- Patient's obstructive disease is severe as defined by: FEV1 ≤45% of predicted
- Patient's hyperinflation is defined by: RV ≥ 150% of predicted
- Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period
Who cannot join
- Patient does not have at least one airway with the intention to be treated with a 9 mm Spiration Valve based on a calibrated balloon sizing of the airway.
- Patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study
- Patient is unable to provide informed consent
- Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures
- Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year and none have occurred in the 3 months prior to baseline testing.
- Patient has giant bulla (> 1/3 volume of lung)
Show all 12Show fewer
- Patient has severe pulmonary hypertension.
- Patient has bronchiectasis
- Patient has evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
- Patient has had prior lung volume reduction surgery, intra-bronchial valve therapy for emphysema, or major lung procedures (lobectomy or greater).
- Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
- Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik, University of Heidelberg
Heidelberg, 69126
Felix Herth, Prof-, +49(0)6221/3961201, herth@uni-heidelberg.de
Felix JF Herth, MD, PhD
About this study
Official title: Post Market Evaluation of the 9mm Spiration Valve System in Patients With Severe Heterogeneous Emphysema
The purpose of this observational study is to investigate the efficacy of 9 mm intrabronchial valve treatment in patients with heterogeneous emphysema and to gain further insights and experience on the treatment with this valve size.
Read the detailed description
This study is designed to evaluate performance of the 9 mm valve system in patients with at least one airway to be treated . Patients with severe airflow obstruction, severe emphysema, significant hyperinflation, and moderate to severe dyspnea are eligible to be evaluated for enrollment in this study. In this study, eligible patients will have severe emphysema in a target lobe with an intact fissure. Patients must be able to tolerate a flexible bronchoscopy procedure. After evaluation of all inclusion and exclusion criteria, with review of the CT data by the core laboratories, patients will be enrolled in the study. The indications for endoscopic reduction of pulmonary volume with intrabronchial valves are presented in various preliminary examinations. The duration of the study is about 7 months for each patient. It involves an examination before the valves are inserted, the valves are inserted within the scope of a bronchoscopy, followed by a follow-up examination directly after the valves are inserted, a follow-up period of at least 3 nights in the appropriate clinic and follow-up visits 14, 30 each , 90 and 180 days after the valves are inserted.
The study is expected to enroll up to 30 patients who complete the 6 month follow-up visit at up to 4 sites with up to 15 patients per site.
- Conditions
- Emphysema
- Being tested
- Implementation of 9 mm intrabronchial valves
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of 9 mm intrabronchial valvesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean changes in target lobe volume
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionJan 2017 (estimated)
- Study completionAug 2017 (estimated)
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.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Lung Clinic Hemer, Asklepios Kliniken Hamburg GmbH, Otto Wagner Hospital
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
- Investigators
- Felix Herth, Prof.Dr.med., Principal investigator, University Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008226
- Sponsor's protocol ID
- TKSPI 001/2014
- Status last verified
- Dec 2016
- First submitted
- 29 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Evaluation of the 9mm Spiration Valve System in Patients With Severe Heterogeneous Emphysema
- ClinicalTrials.gov ID
- NCT03008226
- Acronym / sponsor ID
- TKSPI 001/2014
- Conditions
- Emphysema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Lung Clinic Hemer, Asklepios Kliniken Hamburg GmbH, Otto Wagner Hospital
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 2 Jan 2017 (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 observational study is to investigate the efficacy of 9 mm intrabronchial valve treatment in patients with heterogeneous emphysema and to gain further insights and experience on the treatment with this valve size.
Detailed description
This study is designed to evaluate performance of the 9 mm valve system in patients with at least one airway to be treated . Patients with severe airflow obstruction, severe emphysema, significant hyperinflation, and moderate to severe dyspnea are eligible to be evaluated for enrollment in this study. In this study, eligible patients will have severe emphysema in a target lobe with an intact fissure. Patients must be able to tolerate a flexible bronchoscopy procedure. After evaluation of all inclusion and exclusion criteria, with review of the CT data by the core laboratories, patients will be enrolled in the study. The indications for endoscopic reduction of pulmonary volume with intrabronchial valves are presented in various preliminary examinations. The duration of the study is about 7 months for each patient. It involves an examination before the valves are inserted, the valves are inserted within the scope of a bronchoscopy, followed by a follow-up examination directly after the valves are inserted, a follow-up period of at least 3 nights in the appropriate clinic and follow-up visits 14, 30 each , 90 and 180 days after the valves are inserted.
The study is expected to enroll up to 30 patients who complete the 6 month follow-up visit at up to 4 sites with up to 15 patients per site.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe airflow obstruction, severe emphysema, significant hyperinflation, and moderate to severe dyspnea . Eligible patients will have severe emphysema in a target lobe with an intact fissure
Key inclusion criteria (8 listed)
- Patient is older than 40 years in age
- Patient has severe heterogeneous emphysema with moderate to severe dyspnea as defined as an mMRC of 2 or greater.
- The target lobe and ipsilateral lobe will be separated with an intact fissure, as determined by HRCT (> 90% integrity).
- Patient has received standard-of-care medical management and it has been stable for 6 weeks.
- Patient can walk a minimum of 140 meters in the six minute walk test.
Key exclusion criteria (12 listed)
- Patient does not have at least one airway with the intention to be treated with a 9 mm Spiration Valve based on a calibrated balloon sizing of the airway.
- Patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study
- Patient is unable to provide informed consent
- Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures
- Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year and none have occurred in the 3 months prior to baseline testing.
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 |
|---|---|---|
| Implementation of 9 mm intrabronchial valves | Device | – |
Primary outcome
Mean changes in target lobe volume
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Felix Herth, Prof.Dr.med. principal investigator
University Heidelberg
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 Heidelberg University 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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Herth, Prof. (+49(0)6221/3961201, herth@uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes in target lobe volume (time frame: 180 days). 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 2 Jan 2017.