Emphysema or COPDNEXT STEPNCT03670121
A Pilot Study to Assess Treatment of Patients With Homogeneous Emphysema Using Sequential Segmental Bronchoscopic Thermal Vapor Ablation (NEXT STEP)
A study testing Bronchoscopic Thermal Vapor Ablation (BTVA) in people with Emphysema or COPD, run by Uptake Medical Technology, Inc. at 1 site in Germany.
Trial summary
This study is a Prospective, single arm, single center pilot study following outcomes for 12 months after initial BTVA treatment. The primary objectives of the study are to prospectively document the safety and efficacy of sequential segmental treatment with BTVA in patients with a homogeneous distribution of… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Emphysema or COPD
- What is being tested?
- Bronchoscopic Thermal Vapor Ablation (BTVA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 28 Aug 2018to 12 Jun 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or equal to 40 and ≤ 75 years old
- At least one lung with a homogeneous distribution of emphysema (defined as a heterogeneity index < 1.2 when calculated as the ratio of upper lobe to lower lobe %-950 and when calculated as the ratio of lower lobe to upper lobe %-950) and a fissure integrity score < 95% as measured by CT
- Contralateral lung (to lung targeted for the initial BTVA treatment) with tissue to air ratio > 8%
- FEV1 between 20% and 45% predicted
- TLC > or equal to 100% predicted
- RV > or equal to 200% predicted
Show all 16Show fewer
- Post-rehabilitation 6MWD > 140 meters
- Marked dyspnea scoring > or equal to 2 on the mMRC
- Arterial blood gas levels of: PaCO2 ≤ 50 mm Hg; PaO2 > 45 mm Hg on room air
- Non-smoking for 2 months prior to study enrollment, as confirmed by negative urine point of contact strips or serum cotinine level of ≤ 10 ng/mL, or negative CO Hb test
- Optimized medical management (treatment consistent with GOLD guidelines)
- Evidence of completed pulmonary rehabilitation:
- ≥ 6 weeks out-patient or ≥ 3 weeks in-patient within 6 months of enrollment; or,
- Patient has or continues to participate in regular physical activity beyond activities of daily living (i.e. a walking program) for ≥ 6 weeks with 6 months of enrollment under the supervision of a health care professional
- Current influenza vaccination
- Mentally and physically able to cooperate with the study procedures, follow-up requirements, and are able and willing to provide informed consent to participate in the study.
Who cannot join
- Any condition that would interfere with the completion of the study, follow-up assessments, bronchoscopy, or that would adversely affect study outcomes. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with BTVA. Relevant examples of relevance include immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency
- DLCO < 20% predicted or immeasurable DLCO
- BMI < 18kg/m2 or > 35 kg/m2
- Clinically significant bronchiectasis with more than 30 ml productive cough
- Heart and/or lung transplant, lung volume reduction surgery (LVRS), bullectomy, or thoracic surgery with removal of lung tissue
- Prior lung volume reduction via endobronchial valves(s), stent(s), coil(s), and/or polymer. Patients whose endobronchial valves have been removed can be treated if: all valves removed ≥ 6 months prior to BTVA and baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation
Show all 30Show fewer
- Recent respiratory infections or COPD exacerbation in preceding 6 weeks
- Unstable COPD (any of the following):
- >3 COPD related hospitalizations requiring antibiotics in past 12 months
- COPD related hospitalization in past 3 months
- daily use of systemic steroids, i.e. > 5 mg prednisolone
- Single large bulla (defined as > 1/3 volume of the lobe) or a paraseptal distribution of emphysema in lobe to be treated
- Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
- History of any of the following:
- Left ventricular ejection fraction (EF) ≤ 40%
- Stroke
- Myocardial infarction or acute coronary syndrome in previous year
- Current use of anticoagulants (including warfarin, and NOACs such as dabigatran, rivaroxaban, apixaban, and similar).
- Patient is unable to stop antiplatelet therapy (including dipyridamole, clopidogrel, prasugrel, and ticlopidine) 7 days before and not restart until 7 days after study procedure.
- Known sensitivity to medications required to perform bronchoscopy
- Pulmonary hypertension:
- Peak systolic PAP > 45 mm Hg or
- Mean PAP > 35 mm Hg
- Right heart catheter measurements (if available) will be considered definitive over echocardiography or cardiac scintigraphy measurements
- Newly prescribed morphine derivatives within the last 4 weeks
- Pregnant or breastfeeding
- Pneumothorax or pleural effusion within previous 6 months
- Indwelling pacemaker or implantable cardiac defibrillator (ICD)
- Patients dependent on the sponsor or investigator
- Current enrollment in any other investigational study which has not completed requisite follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess Treatment of Patients With Homogeneous Emphysema Using Sequential Segmental Bronchoscopic Thermal Vapor Ablation
This study is a Prospective, single arm, single center pilot study following outcomes for 12 months after initial BTVA treatment. The primary objectives of the study are to prospectively document the safety and efficacy of sequential segmental treatment with BTVA in patients with a homogeneous distribution of emphysema that are not candidates for endobronchial valve therapy.
Read the detailed description
The study will include patients with severe emphysema as defined by pulmonary function tests, a homogeneous distribution of emphysema as determined by CT, who are not eligible for endobronchial valve therapy based on fissure integrity as determined by CT. Enrollment will continue until 10 patients have been treated per protocol or until a maximum of 15 patients total have been treated.
Patients will be enrolled at Thoraxklinik University of Heidelberg, Germany and followed for twelve (12) months.
The follow up data collected will include pulmonary function testing (spirometry, body plethysmography, DLCO), exercise capacity (six minute walk test) and imaging findings (chest x-ray and CT). Dyspnea score (mMRC) and quality of life questionnaire (SGRQ-C) information will be obtained. Information regarding adverse events, serious adverse events, and major medical complications will be collected at each visit. Serious adverse events will be adjudicated by an independent medical monitor in order to establish relatedness to the InterVapor device and procedure.
Descriptive statistics will be used to summarize all safety and efficacy data. There is no predefined hypothesis regarding safety, or efficacy.
Monitoring of the study will be undertaken as a continuous process to ensure that high-quality data are obtained and to ensure compliance with study procedures.
- Conditions
- Emphysema or COPD
- Being tested
- Bronchoscopic Thermal Vapor Ablation (BTVA)
- Keywords
- COPD, Emphysema, Homogenous, Collateral Ventilation, Vapor, Ablation
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic Thermal Vapor Ablation (BTVA)Device
Also called BTVA, InterVapor
Bronchoscopic vapor delivery to airway segment(s) targeted for treatment
| Study group | Role | What they receive |
|---|---|---|
| BTVA Treatment | Experimental | All patients that will receive Bronchoscopic Thermal Vapor Ablation (BTVA) Treatment Receives: Device: Bronchoscopic Thermal Vapor Ablation (BTVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)
Occurrence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)
Measured: Baseline to 6 months
Change in FEV1 (efficacy endpoint)
Change in FEV1 (efficacy endpoint)
Measured: Baseline to 6 months
Change in St Georges Respiratory Questionnaire for COPD Patients (SGRQ-C) score (efficacy endpoint)
This trial will utilize the SGRQ-C which is a shortened version of the SGRQ questionnaire. The SGRQ is a validated, disease-specific questionnaire that measures health-related quality of life in patients with COPD.
The instrument has 3 domains (activity, symptoms, and impacts) and a total score. A Total and three-component scores are calculated: Symptoms; Activity; Impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. Each component of the questionnaire is scored separately. Sum of maximum possible weights for each component and Total: Symptoms 566.2, Activity 982.9, Impacts 1652.8. Total (sum of maximum for all three components) 3201.9 Higher weights indicate worse outcomes. The difference in the domain scores and total score at follow-up visits relative to baseline will be calculated and reported.
Measured: Baseline to 6 months
Secondary outcomes (9)
Change in FVC
Change in Forced Vital Capacity
Measured: Baseline to 6 months
Change in FRC
Change in Forced Residual Capacity
Measured: Baseline to 6 months
Change in RV
Change in Residual Volume
Measured: Baseline to 6 months
Change in TLC
Change in Total Lung Capacity
Measured: Baseline to 6 months
Change in RV/TLC
Change in Residual Volume/Total Lung Capacity
Measured: Baseline to 6 months
Change in DLCO
Change in Diffusing capacity of the lung for carbon monoxide
Measured: Baseline to 6 months
Change in Modified Medical Research Council (mMRC) Dyspnea scale
Change in dyspnea score.
Grade Degree of Breathlessness Related to Activities Grade 0 No breathlessness except with strenuous exercise Grade 1 Breathlessness when hurrying on the level or walking up a slight hill Grade 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level Grade 3 Stops for breath after walking about 100 yards or a few minutes on the level Grade 4 Too breathless to leave the house or breathless when dressing or undressing Max score=4, Min score=0 One score is reported based on grade. Higher values represent worse outcomes. For patients with a higher mMRC grade (e.g. ≥2) and clinical circumstances consistent with respiratory disease, measuring spirometry (e.g., FEV₁ and FVC), determining the patient's GOLD stage, helps guide therapeutic interventions.
Measured: Baseline to 6 months
Change in 6MWD
Change in six minute walk distance
Measured: Baseline to 6 months
Change in volume of the treated lobe(s)
Change in lung volume assessed by CT
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start28 Aug 2018
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emphysema or COPDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm Pilot Study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uptake Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
- Investigators
- Felix Herth, Principal investigator, Univ.-Prof. Felix JF Herth, Thoraxklinik University of Heidelberg Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670121
- Sponsor's protocol ID
- CSP-2346
- Acronym
- NEXT STEP
- Status last verified
- Nov 2021
- First submitted
- 5 Sep 2018
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
PubMed 33590989
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Treatment of Patients With Homogeneous Emphysema Using Sequential Segmental Bronchoscopic Thermal Vapor Ablation
- ClinicalTrials.gov ID
- NCT03670121
- Acronym / sponsor ID
- NEXT STEP / CSP-2346
- Conditions
- Emphysema or COPD
- Keywords
- COPD, Emphysema, Homogenous, Collateral Ventilation, Vapor, Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Uptake Medical Technology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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.
This study is a Prospective, single arm, single center pilot study following outcomes for 12 months after initial BTVA treatment. The primary objectives of the study are to prospectively document the safety and efficacy of sequential segmental treatment with BTVA in patients with a homogeneous distribution of emphysema that are not candidates for endobronchial valve therapy.
Detailed description
The study will include patients with severe emphysema as defined by pulmonary function tests, a homogeneous distribution of emphysema as determined by CT, who are not eligible for endobronchial valve therapy based on fissure integrity as determined by CT. Enrollment will continue until 10 patients have been treated per protocol or until a maximum of 15 patients total have been treated.
Patients will be enrolled at Thoraxklinik University of Heidelberg, Germany and followed for twelve (12) months.
The follow up data collected will include pulmonary function testing (spirometry, body plethysmography, DLCO), exercise capacity (six minute walk test) and imaging findings (chest x-ray and CT). Dyspnea score (mMRC) and quality of life questionnaire (SGRQ-C) information will be obtained. Information regarding adverse events, serious adverse events, and major medical complications will be collected at each visit. Serious adverse events will be adjudicated by an independent medical monitor in order to establish relatedness to the InterVapor device and procedure.
Descriptive statistics will be used to summarize all safety and efficacy data. There is no predefined hypothesis regarding safety, or efficacy.
Monitoring of the study will be undertaken as a continuous process to ensure that high-quality data are obtained and to ensure compliance with study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm Pilot Study
| Arm | Type | Receives |
|---|---|---|
| BTVA Treatment | Experimental | Device: Bronchoscopic Thermal Vapor Ablation (BTVA)All patients that will receive Bronchoscopic Thermal Vapor Ablation (BTVA) Treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age > or equal to 40 and ≤ 75 years old
- At least one lung with a homogeneous distribution of emphysema (defined as a heterogeneity index < 1.2 when calculated as the ratio of upper lobe to lower lobe %-950 and when calculated as the ratio of lower lobe to upper lobe %-950) and a fissure integrity score < 95% as measured by CT
- Contralateral lung (to lung targeted for the initial BTVA treatment) with tissue to air ratio > 8%
- FEV1 between 20% and 45% predicted
- TLC > or equal to 100% predicted
Key exclusion criteria (30 listed)
- Any condition that would interfere with the completion of the study, follow-up assessments, bronchoscopy, or that would adversely affect study outcomes. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with BTVA. Relevant examples of relevance include immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency
- DLCO < 20% predicted or immeasurable DLCO
- BMI < 18kg/m2 or > 35 kg/m2
- Clinically significant bronchiectasis with more than 30 ml productive cough
- Heart and/or lung transplant, lung volume reduction surgery (LVRS), bullectomy, or thoracic surgery with removal of lung tissue
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 |
|---|---|---|
| Bronchoscopic Thermal Vapor Ablation (BTVA)Also: BTVA, InterVaporBronchoscopic vapor delivery to airway segment(s) targeted for treatment | Device | BTVA Treatment |
Primary outcome
Incidence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)
Time frame: Baseline to 6 months
Occurrence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)
Change in FEV1 (efficacy endpoint)
Time frame: Baseline to 6 months
Change in FEV1 (efficacy endpoint)
Change in St Georges Respiratory Questionnaire for COPD Patients (SGRQ-C) score (efficacy endpoint)
Time frame: Baseline to 6 months
This trial will utilize the SGRQ-C which is a shortened version of the SGRQ questionnaire. The SGRQ is a validated, disease-specific questionnaire that measures health-related quality of life in patients with COPD. The instrument has 3 domains (activity, symptoms, and impacts) and a total score. A Total and three-component scores are calculated: Symptoms; Activity; Impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. Each component of the questionnaire is scored separately. Sum of maximum possible weights for each component and Total: Symptoms 566.2, Activity 982.9, Impacts 1652.8. Total (sum of maximum for all three components) 3201.9 Higher weights indicate worse outcomes. The difference in the domain scores and total score at follow-up visits relative to baseline will be calculated and reported.
9 secondary outcomes
Change in FVC
Time frame: Baseline to 6 months
Change in FRC
Time frame: Baseline to 6 months
Change in RV
Time frame: Baseline to 6 months
Change in TLC
Time frame: Baseline to 6 months
Change in RV/TLC
Time frame: Baseline to 6 months
Change in DLCO
Time frame: Baseline to 6 months
Change in Modified Medical Research Council (mMRC) Dyspnea scale
Time frame: Baseline to 6 months
Change in 6MWD
Time frame: Baseline to 6 months
Change in volume of the treated lobe(s)
Time frame: Baseline to 6 months
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 15 Nov 2021.
- Derived from this study: PubMed 33590989Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
- Individual participant dataSharing planned: No
Related trials for Emphysema or COPD
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
Emphysema or COPD, Emphysema
Recruiting
An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
Emphysema, Pulmonary, Emphysema or COPD
Recruiting
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
Emphysema or COPD
Recruiting
Ultrasound and Respiratory Physiological Signals in Lung Diseases
Interstitial Lung Disease, Interstitial Lung Diseases
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 principal investigator
Univ.-Prof. Felix JF Herth, Thoraxklinik University of Heidelberg Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopic Thermal Vapor Ablation (BTVA) in people with Emphysema or COPD, run by Uptake Medical Technology, Inc. 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 16 inclusion and 30 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 15 Nov 2021. 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 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?
Incidence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint) (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670121, which also lists 1 linked publication.
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 15 Nov 2021.