Lung Cancer, Lung Cancer Metastatic
Conditions
Keywords
Electrosurgery, RF ablation, Minimally invasive, Lung cancer, Lung metastasis, Lung tumor, Primary, Metastatic, Endobronchial ultrasound, EBUS
Brief summary
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.
Interventions
DEVICERF Ablation
The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.
Sponsors
Olympus Corporation of the Americas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor 2. Pathological proof of target nodule/tumor type and malignancy 3. Target nodule/tumor which can be accessed via EBUS bronchoscopy 4. Resection/surgical candidate 5. Participants must be at least 18 years old and able to provide consent
Exclusion criteria
1. Subjects in whom flexible bronchoscopy is contraindicated 2. Target nodule \< 1.0 cm 3. Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor 4. Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives 5. Pacemaker, implantable cardioverter, or other electronic implantable device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ANET Related Peri-procedural Adverse Events | Day 0 | The incidence of reported adverse events and serious adverse events related to the ANET device or procedure |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RF Ablation Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.
RF Ablation: The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | RF Ablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 71 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment Canada | 5 participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
ANET Related Peri-procedural Adverse Events
The incidence of reported adverse events and serious adverse events related to the ANET device or procedure
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RF Ablation | ANET Related Peri-procedural Adverse Events | 0 Adverse Event |