An interventional study of RF Ablation in Lung Cancer and Lung Cancer Metastatic, sponsored by Olympus Corporation of the Americas. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Olympus Corporation of the Americas · Not applicable, Interventional, and Device feasibility
Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.
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.
Exclusion criteria:
Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.
Device: RF Ablation
The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.
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
| Milestone | RF Ablation |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
The incidence of reported adverse events and serious adverse events related to the ANET device or procedure
| Adverse Event | RF Ablation |
|---|---|
| ANET Related Peri-procedural Adverse Events | 0 |
Collected over Day 0. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RF Ablation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | RF Ablation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 4 |
| Age, Continuous(years) | RF Ablation |
|---|---|
| Mean | 71 (51 to 81) |
| Sex: Female, Male(Participants) | RF Ablation |
|---|---|
| Female | 3 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | RF Ablation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | RF Ablation |
|---|---|
| Canada | 5 |
| United States | 1 |
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Olympus Corporation of the Americas