Lung CancerNCT03400748
ANET Electrosurgery Applicator Pilot Evaluation Study
A study testing RF Ablation in people with Lung Cancer and Lung Cancer Metastatic, run by Olympus Corporation of the Americas at 4 sites in 2 countries.
Trial summary
Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Cancer Metastatic
- What is being tested?
- RF Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Apr 2018to 18 Nov 2020
- 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
- Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor
- Pathological proof of target nodule/tumor type and malignancy
- Target nodule/tumor which can be accessed via EBUS bronchoscopy
- Resection/surgical candidate
- Participants must be at least 18 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 other electronic implantable device
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Duke University Medical Center
Durham, North Carolina, 27710
UT MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.
Read the detailed description
This study is a prospective, single arm, single center study that will evaluate the effectiveness of the ANET Electrosurgery Applicator in up to 10 subjects.
Subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. During the surgical procedure, just prior to resection the subject's tumor will be treated with the ANET device. The ANET device uses a bronchoscope to reach the tumor. Ultrasound on the bronchoscope, CT, and X-rays are used to make sure the ANET device is in the tumor. Once in the tumor, the ANET device uses radio-frequency (RF) ablation to treat the tumor. After standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the ANET.
- Conditions
- Lung Cancer, Lung Cancer Metastatic
- Being tested
- RF Ablation
- Keywords
- Electrosurgery, RF ablation, Minimally invasive, Lung cancer, Lung metastasis, Lung tumor, Primary, Metastatic, Endobronchial ultrasound, EBUS
- Medical subject headings
- Lung Neoplasms, Hyperthermia, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF AblationDevice
The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.
| Study group | Role | What they receive |
|---|---|---|
| RF Ablation | Experimental | Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection. Receives: Device: RF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANET Related Peri-procedural Adverse Events
The incidence of reported adverse events and serious adverse events related to the ANET device or procedure
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start23 Apr 2018
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
Why it stopped: business reason
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 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400748
- Sponsor's protocol ID
- 15
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2018
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANET Electrosurgery Applicator Pilot Evaluation Study
- ClinicalTrials.gov ID
- NCT03400748
- Acronym / sponsor ID
- 15
- Conditions
- Lung Cancer, Lung Cancer Metastatic
- Keywords
- Electrosurgery, RF ablation, Minimally invasive, Lung cancer, Lung metastasis, Lung tumor, Primary, Metastatic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business reason
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 27 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.
Detailed description
This study is a prospective, single arm, single center study that will evaluate the effectiveness of the ANET Electrosurgery Applicator in up to 10 subjects.
Subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. During the surgical procedure, just prior to resection the subject's tumor will be treated with the ANET device. The ANET device uses a bronchoscope to reach the tumor. Ultrasound on the bronchoscope, CT, and X-rays are used to make sure the ANET device is in the tumor. Once in the tumor, the ANET device uses radio-frequency (RF) ablation to treat the tumor. After standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the ANET.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF Ablation | Experimental | Device: RF AblationSingle-arm study where subjects receive RF ablation prior to a scheduled surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor
- Pathological proof of target nodule/tumor type and malignancy
- Target nodule/tumor which can be accessed via EBUS bronchoscopy
- Resection/surgical candidate
- Participants must be at least 18 years old and able to provide consent
Key exclusion criteria (5 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 other 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 |
|---|---|---|
| RF AblationThe intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy. | Device | RF Ablation |
Primary outcome
ANET Related Peri-procedural Adverse Events
Time frame: Day 0
The incidence of reported adverse events and serious adverse events related to the ANET device or procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF Ablation in people with Lung Cancer and Lung Cancer Metastatic, run by Olympus Corporation of the Americas at 4 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 5 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: stopped early, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 27 Sep 2021). 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?
ANET Related Peri-procedural Adverse Events (time frame: Day 0). 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 3 Apr 2024.