Lung CancerNCT03272971
Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors
A study testing Radio-frequency Ablation in people with Lung Cancer and Lung Cancer Metastatic, run by Broncus Medical Inc at 1 site in China.
Trial summary
The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell
- What is being tested?
- Radio-frequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2017to 30 Jan 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
- Must be eligible for curative lung resection (lobectomy)
- Tumor/lesion size will be a minimum of 10mm along the minor diameter
- Willing to participate in all aspects of study protocol for duration of the study
- Able to understand study requirements
- Signs informed consent form
Who cannot join
- Any contraindication to bronchoscopy, for example:
- Untreatable life-threatening arrhythmias.
- Inability to adequately oxygenate the patient during the procedure.
- Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated).
- Recent myocardial infarction.
- Previously diagnosed high-grade tracheal obstruction.
Show all 22Show fewer
- Uncorrectable coagulopathy
- Known coagulopathy
- Platelet dysfunction or platelet count <100 x 10^3 cells/mm3
- History of major bleeding with bronchoscopy
- Suspected pulmonary hypertension: additional testing required, such as ECG
- Moderate-to-severe pulmonary fibrosis
- Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD):
- additional testing and PI consent is required
- Bullae >5cm located within the same lobe of target tumor/lesion
- Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RFA
- Ongoing systemic infection
- Contraindications to general anesthesia
- Inability to stop anticoagulants or antiplatelet agents prior to procedure as dictated by the protocol
- Prior thoracic surgery on the same side of the lung as the targeted tumor/lesion
- Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study
- Life expectancy of less than one year.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection.
Read the detailed description
This study is a prospective, single-arm, single-center, pilot study of bronchoscopic Radio-Frequency Ablation (RFA) treatment of target lung lesions, prior to surgical tumor resection. Up to ten (10) subjects will be treated at the investigational site.
Subjects identified for this study will be those that have a surgical resection already scheduled as part of their lung cancer treatment. Patients who have consented to participate in this study (enrolled) will undergo screening assessments to evaluate the inclusion criteria associated with their lung cancer and general health. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will be scheduled for RFA treatment.
Prior to RFA, high-resolution computed tomography (HRCT) scans will be used to characterize the lesion and determine the access pathways for ablation. At the time of the RFA procedure, a point-of-entry, along a bronchial wall, is created under an image-guided navigation system. The RFA catheter is advanced down the access path until it reaches the tumor and RF is administered at the prescribed dose. Upon completion of the RFA treatment, the subject is immediately prepared for surgical resection in accordance with their lung cancer standard of care. There are no follow-up visits as part of this study, the subject is excited following surgical resection.
The resected tissue will undergo pathological evaluation for tissue viability.
- Being tested
- Radio-frequency Ablation
- Keywords
- lung cancer, radiofrequency ablation, bronchoscopy, NSCLC
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-frequency AblationDevice
The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.
| Study group | Role | What they receive |
|---|---|---|
| Radio-frequency Ablation | Experimental | Single-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection. Receives: Device: Radio-frequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFA relate AEs/SAEs
The incidence of reported adverse events and serious adverse events related to the RFA procedure
Measured: Day 0
Feasibility - Ablated Tissue
Semi-quantitative scoring of necrotic tissue assessed by histology
Measured: Day 0
Feasibility - Delivery of Ablation
Treatment meets the required procedural steps/requirements per the Operator's Manual and treatment is delivered to the target tumor per the individual patient navigation plan.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start5 Dec 2017
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Broncus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uptake Medical Technology, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272971
- Sponsor's protocol ID
- Protocol 45
- Status last verified
- Oct 2019
- First submitted
- 31 Aug 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors
- ClinicalTrials.gov ID
- NCT03272971
- Acronym / sponsor ID
- Protocol 45
- Keywords
- lung cancer, radiofrequency ablation, bronchoscopy, NSCLC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Broncus Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Uptake Medical Technology, Inc.
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 6 Sep 2017 (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.
The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection.
Detailed description
This study is a prospective, single-arm, single-center, pilot study of bronchoscopic Radio-Frequency Ablation (RFA) treatment of target lung lesions, prior to surgical tumor resection. Up to ten (10) subjects will be treated at the investigational site.
Subjects identified for this study will be those that have a surgical resection already scheduled as part of their lung cancer treatment. Patients who have consented to participate in this study (enrolled) will undergo screening assessments to evaluate the inclusion criteria associated with their lung cancer and general health. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will be scheduled for RFA treatment.
Prior to RFA, high-resolution computed tomography (HRCT) scans will be used to characterize the lesion and determine the access pathways for ablation. At the time of the RFA procedure, a point-of-entry, along a bronchial wall, is created under an image-guided navigation system. The RFA catheter is advanced down the access path until it reaches the tumor and RF is administered at the prescribed dose. Upon completion of the RFA treatment, the subject is immediately prepared for surgical resection in accordance with their lung cancer standard of care. There are no follow-up visits as part of this study, the subject is excited following surgical resection.
The resected tissue will undergo pathological evaluation for tissue viability.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radio-frequency Ablation | Experimental | Device: Radio-frequency AblationSingle-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
- Must be eligible for curative lung resection (lobectomy)
- Tumor/lesion size will be a minimum of 10mm along the minor diameter
- Willing to participate in all aspects of study protocol for duration of the study
- Able to understand study requirements
Key exclusion criteria (22 listed)
- Any contraindication to bronchoscopy, for example:
- Known coagulopathy
- Platelet dysfunction or platelet count <100 x 10^3 cells/mm3
- History of major bleeding with bronchoscopy
- Suspected pulmonary hypertension: additional testing required, such as ECG
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 |
|---|---|---|
| Radio-frequency AblationThe intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency. | Device | Radio-frequency Ablation |
Primary outcome
RFA relate AEs/SAEs
Time frame: Day 0
The incidence of reported adverse events and serious adverse events related to the RFA procedure
Feasibility - Ablated Tissue
Time frame: Day 0
Semi-quantitative scoring of necrotic tissue assessed by histology
Feasibility - Delivery of Ablation
Time frame: Day 0
Treatment meets the required procedural steps/requirements per the Operator's Manual and treatment is delivered to the target tumor per the individual patient navigation plan.
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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?
A study testing Radio-frequency Ablation in people with Lung Cancer and Lung Cancer Metastatic, run by Broncus Medical Inc at 1 site in China.
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 22 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 1 Nov 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 China. 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: Lack of enrollment). 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?
RFA relate AEs/SAEs (time frame: Day 0). 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 1 Nov 2019.