Cancer of LungNCT03603652
NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
A study testing Microwave Ablation in people with Cancer of Lung and Cancer of the Lung, run by Ethicon, Inc. at 5 sites in United States.
Trial summary
Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Lung, Cancer of the Lung, Lung Cancer
- 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
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jun 2018to 24 Oct 2019
- Phase
- Interventional
- 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
Who may be able to join
- Signed informed consent.
- Patients ≥ 18 years old.
- Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
- Willing to fulfill all follow-up visit requirements.
- Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) < 40%; DLCO (diffusing capacity of the lung for carbon monoxide) < 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease)
- One soft tissue lesion ≤ 2 cm in the outer two thirds of the lung and not closer than 1 cm to the pleura.
- (Outer two thirds of the lung is defined as peripheral beyond the segmental airway, past the segmental bronchi, such that proximal endobronchial soft tissue lesions are avoided; soft tissue lesions should not be contiguous with the pleura)
- Radiographic resolution of pneumonia
Who cannot join
- Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
- Pregnant or breastfeeding.
- Physical or psychological condition that would impair study participation.
- Patients with uncorrectable coagulography at time of screening.
- Patient with implantable devices, including pacemakers or other electronic implants.
- Prior pneumonectomy or bronchiectasis.
Show all 14Show fewer
- Severe neuromuscular disease.
- Platelet count ≤ 50,000/mm3.
- ASA (American Society of Anesthesiologists) score of ≥ 4.
- Inability to tolerate anesthesia.
- Expected survival less than 6 months.
- Clinically significant hypertension.
- Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
- Endobronchial soft tissue lesions proximal to the segmental airways
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 Medically Inoperable Primary Soft Tissue Lesions of the Lung: An Initial Experience
Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.
Read the detailed description
Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to the pleura) will have transbronchial microwave ablation performed using CT imaging. All ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.
Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging.
Patients will be followed for one year following the ablation procedure for efficacy and safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A user experience questionnaire is completed by the treating physician to better understand the ease of the procedure.
- Conditions
- Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer
- Being tested
- Microwave Ablation
- Keywords
- Lung Lesions; Soft Tissue- Lung
- 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
Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound to confirm disease staging.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation | Experimental | Ablations will be performed under general anesthesia via transbronchial approach 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.
Number of Patients Whose Ablation Resulted in Technical Success
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.
Measured: Immediately post-ablation (day 0)
Number of Patients Whose Ablation Resulted in Technique Efficacy
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.
Measured: 30 days post-ablation
User Experience Survey (Part I)
A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
Measured: Immediately post-ablation
User Experience Survey (Part II)
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.
Measured: Immediately post-ablation
User Experience Survey (Part III)
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.
Measured: Immediately post-ablation
User Experience Survey (Part IV)
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.
Measured: Immediately post-ablation
User Experience Survey (Part V)
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.
Measured: Immediately post-ablation
Secondary outcomes (2)
Number of Patients Who Experienced Target Lesion Recurrence
Analyzed at 6 months and 1 year post-ablation via CT imaging
Measured: measured at 6 months and 1 year post-ablation
Number of Patients Who Were Readmitted to the Hospital
Any readmission to the hospital within 30 days of the ablation procedure.
Measured: Within 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 posted27 Jul 2018
- Study start29 Jun 2018
- Primary completion21 Dec 2018
- Study completion24 Oct 2019
Why it stopped: Study originally suspended pending a protocol amendment but study now terminated.
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 of 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Gildea, MD, Principal investigator, The Cleveland ClinicMichael Pritchett, MD, Principal investigator, FirstHealth Moore Regional HospitalJanani Reisenauer, MD, Principal investigator, Mayo ClinicBradley Pua, MD, Principal investigator, CornellJae Kim, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603652
- Sponsor's protocol ID
- NEU_2017_06
- Status last verified
- Dec 2020
- First submitted
- 16 May 2018
- Last updated
- 21 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 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 Medically Inoperable Primary Soft Tissue Lesions of the Lung: An Initial Experience
- ClinicalTrials.gov ID
- NCT03603652
- Acronym / sponsor ID
- NEU_2017_06
- Conditions
- Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer
- Keywords
- Lung Lesions; Soft Tissue- Lung
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study originally suspended pending a protocol amendment but study now terminated.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 21 Dec 2020
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 primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.
Detailed description
Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to the pleura) will have transbronchial microwave ablation performed using CT imaging. All ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.
Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging.
Patients will be followed for one year following the ablation procedure for efficacy and safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A user experience questionnaire is completed by the treating physician to better understand the ease of the procedure.
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 AblationAblations will be performed under general anesthesia via transbronchial approach 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 (8 listed)
- Signed informed consent.
- Patients ≥ 18 years old.
- Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
- Willing to fulfill all follow-up visit requirements.
- Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) < 40%; DLCO (diffusing capacity of the lung for carbon monoxide) < 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease)
Key exclusion criteria (14 listed)
- Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
- Pregnant or breastfeeding.
- Physical or psychological condition that would impair study participation.
- Patients with uncorrectable coagulography at 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 AblationAblations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound to confirm disease staging. | Device | Microwave Ablation |
Primary outcome
Number of Patients Whose Ablation Resulted in Technical Success
Time frame: Immediately post-ablation (day 0)
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.
Number of Patients Whose Ablation Resulted in Technique Efficacy
Time frame: 30 days post-ablation
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.
User Experience Survey (Part I)
Time frame: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
User Experience Survey (Part II)
Time frame: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.
User Experience Survey (Part III)
Time frame: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.
User Experience Survey (Part IV)
Time frame: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.
User Experience Survey (Part V)
Time frame: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.
2 secondary outcomes
Number of Patients Who Experienced Target Lesion Recurrence
Time frame: measured at 6 months and 1 year post-ablation
Number of Patients Who Were Readmitted to the Hospital
Time frame: Within 30 days post-ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Gildea, MD principal investigator
The Cleveland Clinic
Michael Pritchett, MD principal investigator
FirstHealth Moore Regional Hospital
Janani Reisenauer, MD principal investigator
Mayo Clinic
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 Lung and Cancer of the Lung, 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 8 inclusion and 14 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 21 Dec 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?
Yes. Results are posted in the registry (first posted 21 Dec 2020). 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 Patients Whose Ablation Resulted in Technical Success (time frame: Immediately post-ablation (day 0)). The study lists 7 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 21 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.