Airway ObstructionNCT06105606
Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
A study testing AveCure Flexible Microwave Ablation Probe in people with Airway Obstruction and Central Airway Obstruction, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This research is being done to evaluate the feasibility of the AveCure Flexible Microwave destruction of tissue (Ablation) Probe for the treatment of malignant central airway obstruction using a thin, tube-like instrument with a light and a lens for viewing and removing tissue (bronchoscopic). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Airway Obstruction, Central Airway Obstruction
- What is being tested?
- AveCure Flexible Microwave Ablation Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2024to 26 Jan 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age between 18 and 80 years of age and able to provide informed consent.
- Candidate for bronchoscopy under general anesthesia.
- Diagnosis of central airway obstruction (trachea, right main stem bronchus, left main stem bronchus), as evidenced by CT or CT/PET imaging confirmed or suspected to be due to malignant etiology, for which the bronchoscopist has deemed that endoscopic ablation/debridement is indicated (i.e. endobronchial tumors, mixed endobronchial/extrinsic compression lesions).
Who cannot join
- Patients who are unable to understand the informed consent, including potential risks and benefits of the procedure.
- Patients in whom bronchoscopy under general anesthesia is contraindicated.
- 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
- Patients with coagulopathy
- Patients in other therapeutic lung cancer studies
Show all 9Show fewer
- COVID-19 positive patient at the time of the procedure.
- Patients who are pregnant
- Patients with purely extrinsic compression of the airway.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
This research is being done to evaluate the feasibility of the AveCure Flexible Microwave destruction of tissue (Ablation) Probe for the treatment of malignant central airway obstruction using a thin, tube-like instrument with a light and a lens for viewing and removing tissue (bronchoscopic).
The name of the intervention being used in this research study is:
AveCure Flexible Microwave Ablation Probe (handheld, surgical device that delivers microwave energy via flexible probe tip)
Read the detailed description
This research study is a prospective, single-arm, cohort study to evaluate the feasibility of Microwave Ablation (MWA) Probe for the bronchoscopic treatment of malignant lesions causing central airway obstructions (COA). The AveCure prob will be placed in contact with the COA to treat with energy.
The U.S. Food and Drug Administration (FDA) has approved this intervention for use throughout the body, but it has not been approved for the specific indication of central airway obstruction.
Research study procedures include screening for eligibility, hospitalization for bronchoscopy and MWA, blood tests, survey questionnaires, Computerized Tomography (CT) scan imaging, and pulmonary function tests.
Participation in this research study is expected to last about 6 months.
It is expected that about 10 people will take part in this research study.
MedWaves, Inc is funding this research study by providing the ablation probe and generator.
- Conditions
- Airway Obstruction, Central Airway Obstruction
- Being tested
- AveCure Flexible Microwave Ablation Probe
- Keywords
- Endoluminal malignant central airway obstruction, Central airway obstruction
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AveCure Flexible Microwave Ablation ProbeDevice
Also called Avecure 16 Gauge Probe Model 16-123-01-15
Consists of a handheld, surgical device which delivers microwave energy from its microwave antenna. The flexible probe has a 3cm active microwave field that radiates from the tip.
| Study group | Role | What they receive |
|---|---|---|
| AvuCure Microwave Ablation | Experimental | Participants will undergo study procedures as follows:
* Baseline assessments
* Hospital admission for bronchoscopy under general anesthesia and microwave ablation via standard of care.
* Participants will be followed at 1, 3, and 6 months post-procedure. Receives: Device: AveCure Flexible Microwave Ablation Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Failure Rate (FFR)
Feasibility of the AveCure microwave technology to ablate a target malignant central and lobar airway lesions causing > 50% obstruction, defined as at least 9/10 of the planned ablations (90%) successfully performed bronchoscopically according to the study protocol
Measured: 6 months
Secondary outcomes (19)
6-month airway patency rate
6-month airway patency rate defined as the proportion of participants achieve airway patency. Airway patency will be calculated as the minimal airway luminal area at the CAO as a percentage of the average of the distal and proximal airway luminal areas.
Measured: 6 months
Grade 3-5 Treatment-related Toxicity Rate
All grade 3-5 adverse events (AE) with attribution of possibly, probably or definitely related to neoadjuvant treatment based on CTCAEv5 are counted. Rate is the proportion of treated participants with at least one post-baseline safety assessment experiencing at least one of these adverse events during the time of observation.
Measured: Adverse events evaluated 1, 3 and 6 month after procedure.
Airway Obstruction (AO) Rate
AO Rate defined as percentage of airway obstruction assessed at bronchoscopy and on CT scan after the study procedure measured through the Myer-Cotton grading system and percentage change in luminal cross sectional area. Central airway obstruction (CAO) is defined as occlusion of more than 50% of the trachea, mainstem bronchi, bronchus intermedius, or a lobar bronchus.
Measured: CT scan at 1, 3, 6 and 12 months after procedure
Change in Subjective Perception of Dyspnea
subjective perception of dyspnea as measured by the modified Medical Research Council dyspnea scale (mMRC)
Measured: Assessed 1, 3, 6 and 12 months after procedure.
Number and type of additional tools that are used during bronchoscopy.
Measured: Index procedure only (at ablation).
Procedural Bleeding
bleeding assessed by the Nashville scale
Measured: Index procedure only (at ablation).
Change in peak flow measurement
Peak flow measurement using a standard peak flow meter will also be performed by research staff.
Measured: Baseline to 30 days +/- 7 days post ablation
6-month Overall Survival (OS)
6-month OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive.
Measured: 6 months
6-month mechanical ventilation-free survival
6-month mechanical ventilation-free survival is a probability estimated using the Kaplan Meier method; PFS is defined as the duration of time from study entry to documented mechanical ventilation.
Measured: 6 months
Histologic characteristics of tissue ablated with the AveCure microwave technology device.
Measured: Index procedure only (at ablation).
MW number of energy applications
Measured: Index procedure only (at ablation)
MW time of application
seconds
Measured: Index procedure only (at ablation)
Total time of MW ablation
seconds
Measured: Index procedure only (at ablation)
Total energy delivered during MW ablation
mW
Measured: Index procedure only (at ablation)
Temperature during ablation
degrees Celsius
Measured: Index procedure only (at ablation)
Length of ablation procedure
minutes
Measured: Index procedure only (at ablation)
Change in Quality of Life (QoL) as measured by Saint George Respiratory Questionnaire (SGRQ)
Measured: ssessed 1, 3, 6 and 12 months after procedure.
Procedural bleeding
estimated blood loss (mL)
Measured: Index procedure only (at ablation)
Change in Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30)
Measured: Assessed 1, 3, 6 and 12 months after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start8 Mar 2024
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- 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
- NCT06105606
- Sponsor's protocol ID
- 23-131
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2023
- Last updated
- 13 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: \[contact information for Sponsor Investigator or designee\]. 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
- ClinicalTrials.gov ID
- NCT06105606
- Acronym / sponsor ID
- 23-131
- Conditions
- Airway Obstruction, Central Airway Obstruction
- Keywords
- Endoluminal malignant central airway obstruction, Central airway obstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 27 Oct 2023 (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 is being done to evaluate the feasibility of the AveCure Flexible Microwave destruction of tissue (Ablation) Probe for the treatment of malignant central airway obstruction using a thin, tube-like instrument with a light and a lens for viewing and removing tissue (bronchoscopic).
The name of the intervention being used in this research study is:
AveCure Flexible Microwave Ablation Probe (handheld, surgical device that delivers microwave energy via flexible probe tip)
Detailed description
This research study is a prospective, single-arm, cohort study to evaluate the feasibility of Microwave Ablation (MWA) Probe for the bronchoscopic treatment of malignant lesions causing central airway obstructions (COA). The AveCure prob will be placed in contact with the COA to treat with energy.
The U.S. Food and Drug Administration (FDA) has approved this intervention for use throughout the body, but it has not been approved for the specific indication of central airway obstruction.
Research study procedures include screening for eligibility, hospitalization for bronchoscopy and MWA, blood tests, survey questionnaires, Computerized Tomography (CT) scan imaging, and pulmonary function tests.
Participation in this research study is expected to last about 6 months.
It is expected that about 10 people will take part in this research study.
MedWaves, Inc is funding this research study by providing the ablation probe and generator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AvuCure Microwave Ablation | Experimental | Device: AveCure Flexible Microwave Ablation ProbeParticipants will undergo study procedures as follows: * Baseline assessments * Hospital admission for bronchoscopy under general anesthesia and microwave ablation via standard of care. * Participants will be followed at 1, 3, and 6 months post-procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age between 18 and 80 years of age and able to provide informed consent.
- Candidate for bronchoscopy under general anesthesia.
- Diagnosis of central airway obstruction (trachea, right main stem bronchus, left main stem bronchus), as evidenced by CT or CT/PET imaging confirmed or suspected to be due to malignant etiology, for which the bronchoscopist has deemed that endoscopic ablation/debridement is indicated (i.e. endobronchial tumors, mixed endobronchial/extrinsic compression lesions).
Key exclusion criteria (9 listed)
- Patients who are unable to understand the informed consent, including potential risks and benefits of the procedure.
- Patients in whom bronchoscopy under general anesthesia is contraindicated.
- 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
- Patients with coagulopathy
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 Flexible Microwave Ablation ProbeAlso: Avecure 16 Gauge Probe Model 16-123-01-15Consists of a handheld, surgical device which delivers microwave energy from its microwave antenna. The flexible probe has a 3cm active microwave field that radiates from the tip. | Device | AvuCure Microwave Ablation |
Primary outcome
Feasibility Failure Rate (FFR)
Time frame: 6 months
Feasibility of the AveCure microwave technology to ablate a target malignant central and lobar airway lesions causing > 50% obstruction, defined as at least 9/10 of the planned ablations (90%) successfully performed bronchoscopically according to the study protocol
19 secondary outcomes
6-month airway patency rate
Time frame: 6 months
Grade 3-5 Treatment-related Toxicity Rate
Time frame: Adverse events evaluated 1, 3 and 6 month after procedure.
Airway Obstruction (AO) Rate
Time frame: CT scan at 1, 3, 6 and 12 months after procedure
Change in Subjective Perception of Dyspnea
Time frame: Assessed 1, 3, 6 and 12 months after procedure.
Number and type of additional tools that are used during bronchoscopy.
Time frame: Index procedure only (at ablation).
Procedural Bleeding
Time frame: Index procedure only (at ablation).
Change in peak flow measurement
Time frame: Baseline to 30 days +/- 7 days post ablation
6-month Overall Survival (OS)
Time frame: 6 months
6-month mechanical ventilation-free survival
Time frame: 6 months
Histologic characteristics of tissue ablated with the AveCure microwave technology device.
Time frame: Index procedure only (at ablation).
MW number of energy applications
Time frame: Index procedure only (at ablation)
MW time of application
Time frame: Index procedure only (at ablation)
Total time of MW ablation
Time frame: Index procedure only (at ablation)
Total energy delivered during MW ablation
Time frame: Index procedure only (at ablation)
Temperature during ablation
Time frame: Index procedure only (at ablation)
Length of ablation procedure
Time frame: Index procedure only (at ablation)
Change in Quality of Life (QoL) as measured by Saint George Respiratory Questionnaire (SGRQ)
Time frame: ssessed 1, 3, 6 and 12 months after procedure.
Procedural bleeding
Time frame: Index procedure only (at ablation)
Change in Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30)
Time frame: Assessed 1, 3, 6 and 12 months after procedure.
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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: [contact information for 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. This study is not recruiting at the moment.
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 Flexible Microwave Ablation Probe in people with Airway Obstruction and Central Airway Obstruction, 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 3 inclusion and 9 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 13 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?
The study was stopped early (reason given: Low accrual). 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?
Feasibility Failure Rate (FFR) (time frame: 6 months). 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 13 Apr 2026.