ANET Electrosurgery Applicator Pilot Evaluation Study

Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer; Lung Cancer Metastatic
• Intervention / Treatment: Device: RF Ablation

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RF Ablation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ANET Related Peri-procedural Adverse Events	The incidence of reported adverse events and serious adverse events related to the ANET device or procedure	Day 0

Collaborators and Investigators

• Sponsor: Olympus Corporation of the Americas

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): November 18, 2020
• Study Completion (Actual): November 18, 2020

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: EBUS; Lung cancer; Metastatic; Primary; Minimally invasive; Electrosurgery; RF ablation; Endobronchial ultrasound; Lung tumor; Lung metastasis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes