Stage I - II Primary Lung CancerNCT05281237
Avecure Flexible Microwave Ablation Probe For Lung Nodules
A study testing AveCure 16 Gauge Flexible Microwave Ablation Probe in people with Stage I - II Primary Lung Cancer and Stage I Lung Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size. This research study involves microwave ablation (MWA) Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Stage I - II Primary Lung Cancer, Stage I Lung Cancer, Stage II Lung Cancer
- What is being tested?
- AveCure 16 Gauge Flexible Microwave Ablation Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE.
- Pathological proof of target nodule/tumor type and malignancy with specimen considered adequate per institutional laboratory standards
- Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively
- Resection/surgical candidate (lobectomy or greater)
- Participants must be at least 22 years old and able to provide consent
Who cannot join
- Subjects in whom flexible bronchoscopy is contraindicated
- Target nodule < 1.0 cm
- Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
- Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
- Pacemaker, implantable cardioverter, or another electronic implantable device
- Patient cannot tolerate bronchoscopy
Show all 10Show fewer
- Patients with coagulopathy
- Patients in other therapeutic lung cancer studies
- Subject is pregnant or breastfeeding
- COVID-19 positive patient at the time of procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Adnan Majid, MD
Mihir S Parikh, MD
About this study
Official title: Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.
This research study involves microwave ablation (MWA)
Read the detailed description
This will be a single arm, prospective cohort study.
The names of the study intervention involved in this study is:
- Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA)
- A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
- Participants will receive the study intervention and will be followed for 30 days.
- It is expected that about 10 people will take part in this research study.
This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules.
The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.
- Conditions
- Stage I - II Primary Lung Cancer, Stage I Lung Cancer, Stage II Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer
- Being tested
- AveCure 16 Gauge Flexible Microwave Ablation Probe
- Keywords
- Stage I - II primary lung cancer, Stage I Lung Cancer, Stage II Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AveCure 16 Gauge Flexible Microwave Ablation ProbeDevice
Also called Avecure
Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery
| Study group | Role | What they receive |
|---|---|---|
| AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES | Experimental | The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm.
* CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure.
* Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology. Receives: Device: AveCure 16 Gauge Flexible Microwave Ablation Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Planned Ablations.
Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol.
Measured: Day 1
Pathological changes in the tumor tissue.
Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described.
Measured: 4 weeks
Secondary outcomes (2)
Histological changes in lung tissue outside the zone of predicted ablation.
A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described.
Measured: 4 weeks
Immune-histochemical changes in the tumor tissue.
Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Jun 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage I - II Primary 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- MedWaves, Inc, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Jason A Beattie, Beth Israel Deaconess Medical Center
- Investigators
- Jason Beattie, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281237
- Sponsor's protocol ID
- 21-412
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Beattie J, Parrish R, Ayasa L, Aranguren P, Uribe-Buritica FL, Lopez MN, Pineda CM, Cheng G, Senitko M, Abdelghani R, Magge A, Avendano CA, Kheir F, Swenson K, Parikh M, Wilson J, VanderLaan PA, Gangadharan S, Majid A. Safety and feasibility of bronchoscopic microwave ablation technology for peripheral lung cancer: a multi-center, prospective, single-arm study protocol. BMC Surg. 2025 Oct 24;25(1):497. doi: 10.1186/s12893-025-03230-y.
PubMed 41137055
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
- ClinicalTrials.gov ID
- NCT05281237
- Acronym / sponsor ID
- 21-412
- Conditions
- Stage I - II Primary Lung Cancer, Stage I Lung Cancer, Stage II Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer
- Keywords
- Stage I - II primary lung cancer, Stage I Lung Cancer, Stage II Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- MedWaves, Inc, Dana-Farber Cancer Institute
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Mar 2022 (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.
This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.
This research study involves microwave ablation (MWA)
Detailed description
This will be a single arm, prospective cohort study.
The names of the study intervention involved in this study is:
- Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA)
- A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
- Participants will receive the study intervention and will be followed for 30 days.
- It is expected that about 10 people will take part in this research study.
This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules.
The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES | Experimental | Device: AveCure 16 Gauge Flexible Microwave Ablation ProbeThe research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm. * CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure. * Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE.
- Pathological proof of target nodule/tumor type and malignancy with specimen considered adequate per institutional laboratory standards
- Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively
- Resection/surgical candidate (lobectomy or greater)
- Participants must be at least 22 years old and able to provide consent
Key exclusion criteria (10 listed)
- Subjects in whom flexible bronchoscopy is contraindicated
- Target nodule < 1.0 cm
- Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
- Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
- Pacemaker, implantable cardioverter, or another electronic implantable device
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 |
|---|---|---|
| AveCure 16 Gauge Flexible Microwave Ablation ProbeAlso: AvecureMicrowave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery | Device | AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES |
Primary outcome
Rate of Planned Ablations.
Time frame: Day 1
Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol.
Pathological changes in the tumor tissue.
Time frame: 4 weeks
Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described.
2 secondary outcomes
Histological changes in lung tissue outside the zone of predicted ablation.
Time frame: 4 weeks
Immune-histochemical changes in the tumor tissue.
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 41137055Beattie J, Parrish R, Ayasa L, Aranguren P, Uribe-Buritica FL, Lopez MN, Pineda CM, Cheng G, Senitko M, Abdelghani R, Magge A, Avendano CA, Kheir F, Swenson K, Parikh M, Wilson J, VanderLaan PA, Gangadharan S, Majid A. Safety and feasibility of bronchoscopic microwave ablation technology for peripheral lung cancer: a multi-center, prospective, single-arm study protocol. BMC Surg. 2025 Oct 24;25(1):497. doi: 10.1186/s12893-025-03230-y.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Jason Beattie, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AveCure 16 Gauge Flexible Microwave Ablation Probe in people with Stage I - II Primary Lung Cancer and Stage I Lung Cancer, run by Beth Israel Deaconess Medical Center at 1 site 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Beattie, MD ((617) 632- 8252, jbeattie@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Planned Ablations. (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281237, which also lists 1 linked publication.
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 8 Apr 2026.