Cancer, LungNAVABLATENCT03569111
Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter
An observational study of Cancer, Lung and Cancer, Metastatic to Lung, run by Medtronic - MITG at 2 sites in 2 countries.
Trial summary
The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in clinical use. This is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung, Cancer, Metastatic to Lung
- What is being tested?
- Bronchoscopic ablation catheter
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Feb 2019to 28 Oct 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Subjects included must have a cancerous lung nodule, and will be candidates for an elective ENB and lung ablation procedure. Subjects themselves will need to provide written consent and agree to attend study visits and complete questionnaires. Up to 30 subjects will be enrolled in this study.
Who may be able to join
- Subject is ≥ 18 years of age
- Subject has provided informed consent
- Subject is able and willing to comply with the study follow-up schedule
- Subject has a definitive diagnosis of cancer in the lung
- Target nodule is ≤ 30mm in maximum diameter
- There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure
Show all 10Show fewer
- Subject is a candidate for an elective electromagnetic navigation bronchoscopy (ENB) procedure
- Subject is a candidate for an elective lung ablation procedure according to standard of care and product Instructions for Use
- Subject is not a candidate for lung surgery or refuses lung surgery
- Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT
Who cannot join
- Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
- Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema
- Female subjects who are pregnant or nursing as determined by standard site practices
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- The investigator determines that participation in the study may jeopardize the safety or welfare of the subject
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in clinical use.
This is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. The study is designed to characterize the safety and performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology.
Read the detailed description
The primary objective of this prospective, single-arm, multicenter, non-randomized study is to characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology device in subjects undergoing lung ablation procedures.
The primary endpoint is the composite rate of adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
The following secondary endpoints will be evaluated:
- Composite rate of serious adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
- Composite rate of all adverse events related to the procedure or study devices through 1-month follow-up.
- Composite rate of all serious adverse events related to the procedure or study devices through 1-month follow-up.
- Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
- Quality of life (EQ-5D Scale)
- Technical success
- Technique efficacy
- Conditions
- Cancer, Lung, Cancer, Metastatic to Lung
- Being tested
- Bronchoscopic ablation catheter
- Keywords
- Lung Nodule, Bronchoscopy, Ablation, Microwave
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic ablation catheterDevice
The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is deployed endoscopically and will be used to conduct bronchoscopic ablations in the lung using the superDimension™ navigation system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
The primary endpoint is the rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
Measured: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
Secondary outcomes (7)
Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
Measured: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
Number of Participants With AEs Related to Study Procedure or Study Devices
Rate of all AEs related to the procedure or study devices through 1-month follow-up.
Rate of all AEs related to the procedure or study devices through 1-month follow-up was also measured based on Common Terminology Criteria for Adverse Events (CTCAE) classification. CTCAE grading is evaluated on a scale from 1-5 (1 - mild; intervention not indicated; 5 - most severe; death related to AE). Subjects could have more than one AE with different CTCAE Grades.
Measured: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
Number of Participants With SAEs Related to the Study Procedure or Study Devices
Rate of all SAEs related to the procedure or study devices through 1-month follow-up.
Measured: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
Score of Patient Satisfaction, Pain, and Breathlessness
Patient satisfaction, pain, and breathlessness (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
At the 1-month visit, subjects assessed their pain/discomfort and breathlessness based on how they recall feeling at 3 different timepoints. The timepoints were immediately, one week, and one month after the bronchoscopic ablation procedure. Pain or discomfort were evaluated on a scale from 0-10 (10 - severe/interferes with basic needs). Breathlessness was evaluated on a scale from 1-5 (5 - too breathless to leave the house, or breathless when undressing).
Subjects also evaluated their willingness to have the procedure performed again on a scale from 1-5 (5 - extremely likely), how likely they would recommend the procedure to family and friends on a scale from 1-5 (5 - extremely likely), and how satisfied they were with the procedure on a scale from 1-5 (5 - extremely satisfied).
Measured: Immediately following the procedure, 1 week post-procedure, 1-month post-procedure; all were collected at the 1-month follow-up visit (20-40 days post-procedure)
Score of Current Health State From Quality of Life Survey
Quality of life evaluation based on EuroQol [EQ-5D-3L] survey. The questions from the survey surround current health status. The subjects assessed their current health state on a scale of 0-100 (100 being the best health state imaginable).
Measured: Baseline and 1-month
Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol
Technical success: An evaluation of whether the lung nodule was treated according to the study protocol as determined at the immediate post-procedural timepoint. This is in contrast to procedures in which the protocol could not be executed completely, either for technical reasons or for reasons related to comorbid disease.
Measured: Immediately post-procedure
Number of Lung Nodules Evaluated as Being Effectively Ablated
Technique efficacy: An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation of the nodule was achieved as evidenced by CT imaging follow-up 1-month post-procedure (including a window of 20-40 days post-procedure).
Measured: 1-month follow-up (an average of 20-40 days post-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start27 Feb 2019
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer, LungStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelvin Lau, MA DPhil FRCS(CTh), Principal investigator, St Bartholomew's Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569111
- Sponsor's protocol ID
- MDT18010ILSBA
- Acronym
- NAVABLATE
- Status last verified
- Apr 2022
- First submitted
- 14 Jun 2018
- Last updated
- 15 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
- ClinicalTrials.gov ID
- NCT03569111
- Acronym / sponsor ID
- NAVABLATE / MDT18010ILSBA
- Conditions
- Cancer, Lung, Cancer, Metastatic to Lung
- Keywords
- Lung Nodule, Bronchoscopy, Ablation, Microwave
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 15 Nov 2022
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 investigation is to characterize the safety and performance of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in clinical use.
This is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. The study is designed to characterize the safety and performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology.
Detailed description
The primary objective of this prospective, single-arm, multicenter, non-randomized study is to characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology device in subjects undergoing lung ablation procedures.
The primary endpoint is the composite rate of adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
The following secondary endpoints will be evaluated:
- Composite rate of serious adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
- Composite rate of all adverse events related to the procedure or study devices through 1-month follow-up.
- Composite rate of all serious adverse events related to the procedure or study devices through 1-month follow-up.
- Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
- Quality of life (EQ-5D Scale)
- Technical success
- Technique efficacy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects included must have a cancerous lung nodule, and will be candidates for an elective ENB and lung ablation procedure. Subjects themselves will need to provide written consent and agree to attend study visits and complete questionnaires. Up to 30 subjects will be enrolled in this study.
Key inclusion criteria (10 listed)
- Subject is ≥ 18 years of age
- Subject has provided informed consent
- Subject is able and willing to comply with the study follow-up schedule
- Subject has a definitive diagnosis of cancer in the lung
- Target nodule is ≤ 30mm in maximum diameter
Key exclusion criteria (5 listed)
- Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
- Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema
- Female subjects who are pregnant or nursing as determined by standard site practices
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- The investigator determines that participation in the study may jeopardize the safety or welfare of the subject
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 ablation catheterThe Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is deployed endoscopically and will be used to conduct bronchoscopic ablations in the lung using the superDimension™ navigation system. | Device | – |
Primary outcome
Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
Time frame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
The primary endpoint is the rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
7 secondary outcomes
Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
Time frame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
Number of Participants With AEs Related to Study Procedure or Study Devices
Time frame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
Number of Participants With SAEs Related to the Study Procedure or Study Devices
Time frame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
Score of Patient Satisfaction, Pain, and Breathlessness
Time frame: Immediately following the procedure, 1 week post-procedure, 1-month post-procedure; all were collected at the 1-month follow-up visit (20-40 days post-procedure)
Score of Current Health State From Quality of Life Survey
Time frame: Baseline and 1-month
Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol
Time frame: Immediately post-procedure
Number of Lung Nodules Evaluated as Being Effectively Ablated
Time frame: 1-month follow-up (an average of 20-40 days post-procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kelvin Lau, MA DPhil FRCS(CTh) principal investigator
St Bartholomew's Hosptial
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Lung and Cancer, Metastatic to Lung, run by Medtronic - MITG at 2 sites in 2 countries.
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 10 inclusion and 5 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 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 15 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology (time frame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)). 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 15 Nov 2022.