Cancer of the LungNCT03713099
NEUWAVE Flexible Probe Study #2
A study testing Microwave ablation in people with Cancer of the Lung and Lung Cancer, run by Ethicon, Inc. at 5 sites in United States.
Trial summary
Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Lung, Lung Cancer, Neoplasms, Lung
- What is being tested?
- Microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Jul 2020to 31 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Patients greater or equal to 18 years of age
- Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG])
- Willing to fulfill all follow-up visit requirements
- Medically inoperable and operable secondary soft tissue lesion(s) of the lung
- A maximum of two ipsilateral soft tissue lesions less than or equal to 2cm in the outer two-thirds of the lung and not closer than 1cm to the pleura. Lesion size must be measured with at least 2-dimensional imaging.
Who cannot join
- Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
- Pregnant or breastfeeding
- Physical or psychological condition that would impair study participation
- Patients with uncorrectable coagulopathy at the time of screening
- Patient with implantable devices, including pacemakers or other electronic implants
- Prior pneumonectomy or bronchiectasis
Show all 16Show fewer
- Severe neuromuscular disease
- Patient count less than or equal to 50,000/mm cubed
- ASA (American Society of Anesthesiologists) score of greater than or equal to 4
- Inability to tolerate anesthesia
- Expected survival less than 6 months
- Clinically significant hypertension
- Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions (however, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted)
- Endobronchial soft tissue lesions proximal to the segmental airways
- Imaging findings of active pulmonary infection
- The patient was judged unsuitable for study participation by the Investigator for any other reason.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cleveland Clinic
Cleveland, Ohio, 44195
City of Hope
Duarte, California, 91010
New York Presbyterian-Weill Cornell Medicine
New York, New York, 10065
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung
Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation.
Read the detailed description
Adult patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung less than 2cm will undergo transbronchial microwave ablation performed by an interventional pulmonologist or thoracic surgeon using cone beam CT imaging for probe guidance and confirmation on ablation outcome. All treated patients will be followed for one year following the ablation procedure for efficacy and safety.
- Conditions
- Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma
- Being tested
- Microwave ablation
- Keywords
- Microwave Ablation
- 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.
Microwave ablationDevice
Microwave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation | Experimental | Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon. Receives: Device: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device User Experience Survey
The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the NEUWAVE microwave ablation system. The questionnaire asks approximately 30 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating physician at the completion of each ablation. A summary of all treating physician responses will be generated at the completion of the study to summarize the overall user experience with the device.
Measured: Day of ablation (day 0)
Technical Success (lesion completely ablated)
Technical Success is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, immediately following the ablation procedure.
Measured: Day of ablation (day 0)
Technique Efficacy (lesion completely ablated)
Technique Efficacy is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, at Visit 3 (i.e. 30 days post-ablation).
Measured: 30 days post-ablation
Secondary outcomes (6)
Adverse Events
Any AEs attributable to the ablation procedure, including all device-related, procedure-related, and SAEs, evaluated from the start of the ablation procedure throughout the entirety of the study (i.e. through 1 year post-ablation).
Measured: 1 year post-ablation
Primary Efficacy Rate
The Primary Efficacy Rate is the percentage of target lesions successfully eradicated following the first ablation procedure, as assessed using CT imaging by the treating physician on the day of ablation.
Measured: Day of ablation (day 0)
Secondary Efficacy Rate
The Secondary Efficacy Rate is defined as the percentage of soft tissue lesions that have undergone successful repeat ablations following identification of local soft tissue lesions progression, as assessed using CT imaging by the treating physician throughout the entirety of the study (i.e. 1 year post-ablation).
Measured: 1 year post-ablation
Target Lesion Recurrence
Target Lesion Recurrence is defined as the reappearance of the lesion(s) at the treated site, as assessed using CT imaging by the treating physician throughout the entirety of the study (i.e. through 1 year post-ablation).
Measured: 1 year post-ablation
Length of Hospital Stay
The Length of Hospital Stay is defined as the length of time of hospitalization from the end of the ablation procedure to the time of discharge (up to 23 hours post-ablation).
Measured: Day of ablation (day 0)
Hospital Readmission Rate
The Hospital Readmission Rate is defined as the percentage of patients who were readmitted to the hospital within 30 days of the ablation procedure.
Measured: 30 days post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start31 Jul 2020 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Why it stopped: Changed study design prior to any patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the LungStudies 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713099
- Sponsor's protocol ID
- NEU_2018_01
- Status last verified
- May 2020
- First submitted
- 18 Oct 2018
- Last updated
- 2 Jun 2020
- 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung
- ClinicalTrials.gov ID
- NCT03713099
- Acronym / sponsor ID
- NEU_2018_01
- Conditions
- Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma
- Keywords
- Microwave Ablation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changed study design prior to any patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 19 Oct 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.
Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation.
Detailed description
Adult patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung less than 2cm will undergo transbronchial microwave ablation performed by an interventional pulmonologist or thoracic surgeon using cone beam CT imaging for probe guidance and confirmation on ablation outcome. All treated patients will be followed for one year following the ablation procedure for efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation | Experimental | Device: Microwave ablationMicrowave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent
- Patients greater or equal to 18 years of age
- Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG])
- Willing to fulfill all follow-up visit requirements
- Medically inoperable and operable secondary soft tissue lesion(s) of the lung
Key exclusion criteria (16 listed)
- Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
- Pregnant or breastfeeding
- Physical or psychological condition that would impair study participation
- Patients with uncorrectable coagulopathy at the time of screening
- Patient with implantable devices, including pacemakers or other electronic implants
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 |
|---|---|---|
| Microwave ablationMicrowave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging. | Device | Microwave Ablation |
Primary outcome
Device User Experience Survey
Time frame: Day of ablation (day 0)
The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the NEUWAVE microwave ablation system. The questionnaire asks approximately 30 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating physician at the completion of each ablation. A summary of all treating physician responses will be generated at the completion of the study to summarize the overall user experience with the device.
Technical Success (lesion completely ablated)
Time frame: Day of ablation (day 0)
Technical Success is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, immediately following the ablation procedure.
Technique Efficacy (lesion completely ablated)
Time frame: 30 days post-ablation
Technique Efficacy is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, at Visit 3 (i.e. 30 days post-ablation).
6 secondary outcomes
Adverse Events
Time frame: 1 year post-ablation
Primary Efficacy Rate
Time frame: Day of ablation (day 0)
Secondary Efficacy Rate
Time frame: 1 year post-ablation
Target Lesion Recurrence
Time frame: 1 year post-ablation
Length of Hospital Stay
Time frame: Day of ablation (day 0)
Hospital Readmission Rate
Time frame: 30 days post-ablation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Cancer of the Lung and Lung Cancer, run by Ethicon, Inc. at 5 sites in United States.
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 16 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: withdrawn, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Device User Experience Survey (time frame: Day of ablation (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 2 Jun 2020.