NCT03400748

ANET Electrosurgery Applicator Pilot Evaluation Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Olympus Corporation of the Americas · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Lung Cancer Metastatic

Interventions

Type	Name	Description
DEVICE	RF Ablation	The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.

Timeline

• Start date: 2018-04-23
• Primary completion: 2020-11-18
• Completion: 2020-11-18
• First posted: 2018-01-17
• Last updated: 2024-04-03
• Results posted: 2021-09-27

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study