EmphysemaHEAT-LVRCNCT02835001
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil
A study testing Bronchoscopy and Lung Volume Reduction Coil (HEAT-LVRC) in people with Emphysema, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- Bronchoscopy and Lung Volume Reduction Coil (HEAT-LVRC)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2019to 15 Jun 2019
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe emphysema (recent CT-scan (< 6 mois) )
- Age > 35 ans
- Modified Medical Research Council Scale (mMRC) > 2
- Forced expiratory volume in one second (FEV1) post-bronchodilatator < 45%
- Residual volume > 175%
- Total Pulmonary capacity > 100%
Who cannot join
- Forced expiratory volume in one second (FEV1) variability > 20% after bronchodilatator
- Carbon Monoxide Diffusing Capacity (TLCO) < 20%
- Recurrent respiratory infection Infections with clinics symptoms
- Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography > 50 mm Hg
- Impossibility to walk more that 140 meter (6 min test)
- Surgery history of volume reduction or pulmonary transplantation
- Broncho-dilatation with clinic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema
Read the detailed description
Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.
- Conditions
- Emphysema
- Being tested
- Bronchoscopy, Lung Volume Reduction Coil (HEAT-LVRC)
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Two sequences of 30 minutes are necessary by patient
Lung Volume Reduction Coil (HEAT-LVRC)Device
Bronchoscopy with Heat-LVRC
| Study group | Role | What they receive |
|---|---|---|
| Patient with severe emphysema | Other | Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy Receives: Procedure: Bronchoscopy; Device: Lung Volume Reduction Coil (HEAT-LVRC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperinflation Assessment After Treatment
Assessed by Lung Volume Reduction Coil
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start15 Jan 2019
- Primary completion15 Jan 2019
- Study completion15 Jun 2019
Why it stopped: change of technique
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 University Hospital, ToulouseThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Guibert, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835001
- Sponsor's protocol ID
- RC31/15/7857
- Acronym
- HEAT-LVRC
- Status last verified
- Aug 2019
- First submitted
- 13 Jul 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema
- ClinicalTrials.gov ID
- NCT02835001
- Acronym / sponsor ID
- HEAT-LVRC / RC31/15/7857
- Conditions
- Emphysema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change of technique
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 15 Jul 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.
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema
Detailed description
Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with severe emphysema | Other | Procedure: Bronchoscopy, Device: Lung Volume Reduction Coil (HEAT-LVRC)Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Severe emphysema (recent CT-scan (< 6 mois) )
- Age > 35 ans
- Modified Medical Research Council Scale (mMRC) > 2
- Forced expiratory volume in one second (FEV1) post-bronchodilatator < 45%
- Residual volume > 175%
Key exclusion criteria (7 listed)
- Forced expiratory volume in one second (FEV1) variability > 20% after bronchodilatator
- Carbon Monoxide Diffusing Capacity (TLCO) < 20%
- Recurrent respiratory infection Infections with clinics symptoms
- Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography > 50 mm Hg
- Impossibility to walk more that 140 meter (6 min test)
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 |
|---|---|---|
| BronchoscopyTwo sequences of 30 minutes are necessary by patient | Procedure or surgery | Patient with severe emphysema |
| Lung Volume Reduction Coil (HEAT-LVRC)Bronchoscopy with Heat-LVRC | Device | Patient with severe emphysema |
Primary outcome
Hyperinflation Assessment After Treatment
Time frame: 3 months
Assessed by Lung Volume Reduction Coil
Results and safety
The study was stopped early (reason given: change of technique). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- 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.
Nicolas Guibert, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy and Lung Volume Reduction Coil (HEAT-LVRC) in people with Emphysema, run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 7 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 21 Aug 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 France. 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: change of technique). 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?
Hyperinflation Assessment After Treatment (time frame: 3 months). 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 21 Aug 2019.