Lung DiseasesNCT04131777
Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
An observational study of Lung Diseases, run by Broncus Medical Inc at 1 site in Germany.
Trial summary
A post-market study to assess the performance and safety of a RF ablation catheter to bronchoscopically ablate lung lesions will be evaluated in patients with confirmed diagnosis of non-small cell lung cancer or metastatic lung lesions who are scheduled for surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Radiofrequency (RF) catheter
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 9 Dec 2019to Nov 2020
- 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 diagnosed with non-small cell lung cancer (NSCLC) and/or pulmonary metastases that are recommended for curative lung resection (pneumonectomy, lobectomy). Enrolled patients will have a microscopically confirmed malignancy, ensuring patients are surgical candidates.
Who may be able to join
- Age ≥ 18 years at screening
- Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
- Eligible for standard of practice lung resection (pneumonectomy, lobectomy)
- Tumor/lesion > 2cm along the major diameter with no visible necrosis
- Signed informed consent form
Who cannot join
- An implantable pacemaker, defibrillator, or other active implants
- Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik Heidelberg
Heidelberg
Michaela Korthoeber, Coordinator, +49 6221 396 8253, michaela.korthoeber@med.uni-heidelberg.de
Felix Herth, MD PhD
About this study
A post-market study to assess the performance and safety of a RF ablation catheter to bronchoscopically ablate lung lesions will be evaluated in patients with confirmed diagnosis of non-small cell lung cancer or metastatic lung lesions who are scheduled for surgical resection.
Read the detailed description
This study is a prospective, single-arm, multi-center, post-market study of bronchoscopic radio frequency (RF) ablation treatment malignant lung lesions prior to surgical resection. Up to 15 patients will be treated at the participating sites.
Patients identified for the study will have been scheduled for surgical resection as part of their treatment for lung lesions. The RF ablation procedure will be performed during a standard-of-care bronchoscopic procedure at minimum of 24 hours prior to resection. The patients exits the study following surgical resection. The resected tissue will undergo pathological evaluation for tissue viability.
- Conditions
- Lung Diseases
- Being tested
- Radiofrequency (RF) catheter
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency (RF) catheterDevice
Also called EMPOWER® RF Catheter
A catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation
| Study group | Role | What they receive |
|---|---|---|
| Roll-in | Initial patients enrolled until optimal RF algorithm is determined Receives: Device: Radiofrequency (RF) catheter | |
| Optimized | Patients treated using optimal RF algorithm Receives: Device: Radiofrequency (RF) catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion
Maximum diameter (in mm) of ablation zone (thermal necrosis) surrounding treated lesion as measured in resected tissue by quantitative histopathological and gross pathological analysis
Measured: The interval between ablation and tissue resection for pathological analysis is a minimum of 24 hours, but the exact interval depends on the investigator's standard of care
Performance - ability of the user and device to deliver ablative treatment in accordance with the catheter's Instructions for Use
The ability of the ablation treatment to be delivered as per the Instructions for Use will be assessed using a binary categorical scale (yes/no)
Measured: Assessed at the time of the RF ablation procedure
Safety - Adverse events (AEs) and serious adverse events (SAEs)
The incidence of reported adverse events and serious adverse events related to the RF ablation procedure/device
Measured: AEs and SAEs related to the RF procedure/device will be reported for the interval beginning with the RF ablation procedure and ending with the surgical resection of the ablated lung tissueion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start9 Dec 2019
- Primary completionAug 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Broncus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uptake Medical Technology, Inc.
- Responsible party
- Sponsor
- Investigators
- Felix J Herth, MD, PhD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131777
- Sponsor's protocol ID
- Protocol 46
- Status last verified
- Mar 2020
- First submitted
- 9 Oct 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
- ClinicalTrials.gov ID
- NCT04131777
- Acronym / sponsor ID
- Protocol 46
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Broncus Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Uptake Medical Technology, Inc.
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 18 Oct 2019 (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.
A post-market study to assess the performance and safety of a RF ablation catheter to bronchoscopically ablate lung lesions will be evaluated in patients with confirmed diagnosis of non-small cell lung cancer or metastatic lung lesions who are scheduled for surgical resection.
Detailed description
This study is a prospective, single-arm, multi-center, post-market study of bronchoscopic radio frequency (RF) ablation treatment malignant lung lesions prior to surgical resection. Up to 15 patients will be treated at the participating sites.
Patients identified for the study will have been scheduled for surgical resection as part of their treatment for lung lesions. The RF ablation procedure will be performed during a standard-of-care bronchoscopic procedure at minimum of 24 hours prior to resection. The patients exits the study following surgical resection. The resected tissue will undergo pathological evaluation for tissue viability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roll-in | – | Device: Radiofrequency (RF) catheterInitial patients enrolled until optimal RF algorithm is determined |
| Optimized | – | Device: Radiofrequency (RF) catheterPatients treated using optimal RF algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with non-small cell lung cancer (NSCLC) and/or pulmonary metastases that are recommended for curative lung resection (pneumonectomy, lobectomy). Enrolled patients will have a microscopically confirmed malignancy, ensuring patients are surgical candidates.
Key inclusion criteria (5 listed)
- Age ≥ 18 years at screening
- Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
- Eligible for standard of practice lung resection (pneumonectomy, lobectomy)
- Tumor/lesion > 2cm along the major diameter with no visible necrosis
- Signed informed consent form
Key exclusion criteria (2 listed)
- An implantable pacemaker, defibrillator, or other active implants
- Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation
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 |
|---|---|---|
| Radiofrequency (RF) catheterAlso: EMPOWER® RF CatheterA catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation | Device | Optimized, Roll-in |
Primary outcome
Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion
Time frame: The interval between ablation and tissue resection for pathological analysis is a minimum of 24 hours, but the exact interval depends on the investigator's standard of care
Maximum diameter (in mm) of ablation zone (thermal necrosis) surrounding treated lesion as measured in resected tissue by quantitative histopathological and gross pathological analysis
Performance - ability of the user and device to deliver ablative treatment in accordance with the catheter's Instructions for Use
Time frame: Assessed at the time of the RF ablation procedure
The ability of the ablation treatment to be delivered as per the Instructions for Use will be assessed using a binary categorical scale (yes/no)
Safety - Adverse events (AEs) and serious adverse events (SAEs)
Time frame: AEs and SAEs related to the RF procedure/device will be reported for the interval beginning with the RF ablation procedure and ending with the surgical resection of the ablated lung tissueion
The incidence of reported adverse events and serious adverse events related to the RF ablation procedure/device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- 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 J Herth, MD, PhD principal investigator
Heidelberg University
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 Lung Diseases, run by Broncus Medical 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 5 inclusion and 2 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 27 Mar 2020. 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 Julie Arneson, BSc (206 926-7408, jarneson@uptakemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion (time frame: The interval between ablation and tissue resection for pathological analysis is a minimum of 24 hours, but the exact interval depends on the investigator's standard of care). 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?
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 27 Mar 2020.