ANET Electrosurgery Applicator Pilot Evaluation Study

Not Applicable

Terminated

• Conditions: Lung Cancer Metastatic; Lung Cancer
• Interventions: Device: RF Ablation

• Registration Number: NCT03400748
• Lead Sponsor: Olympus Corporation of the Americas

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.

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Study Start: 2018-04-23
• Primary Completion: 2020-11-18
• Study Completion: 2020-11-18
• Results First Submitted: 2021-06-25
• Results First Submitted QC: 2021-09-23
• Results First Posted: 2021-09-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RF Ablation	RF Ablation	Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

UT MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada