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ANET Electrosurgery Applicator Pilot Evaluation Study

Primary Purpose

Lung Cancer, Lung Cancer Metastatic

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

RF Ablation

About this trial

This is an interventional device feasibility trial for Lung Cancer focused on measuring Electrosurgery, RF ablation, Minimally invasive, Lung cancer, Lung metastasis, Lung tumor, Primary, Metastatic, Endobronchial ultrasound, EBUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor
Pathological proof of target nodule/tumor type and malignancy
Target nodule/tumor which can be accessed via EBUS bronchoscopy
Resection/surgical candidate
Participants must be at least 18 years old and able to provide consent

Exclusion criteria:

Subjects in whom flexible bronchoscopy is contraindicated
Target nodule < 1.0 cm
Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
Pacemaker, implantable cardioverter, or other electronic implantable device

Sites / Locations

Beth Israel Deaconess Medical Center
Duke University Medical Center
UT MD Anderson Cancer Center
Toronto General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RF Ablation

Arm Description

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

Outcomes

Primary Outcome Measures

ANET Related Peri-procedural Adverse Events

The incidence of reported adverse events and serious adverse events related to the ANET device or procedure

Secondary Outcome Measures

Full Information

NCT ID

NCT03400748

First Posted

January 9, 2018

Last Updated

September 23, 2021

Sponsor

Olympus Corporation of the Americas

1. Study Identification

Unique Protocol Identification Number

NCT03400748

Brief Title

ANET Electrosurgery Applicator Pilot Evaluation Study

Official Title

ANET Electrosurgery Applicator Pilot Evaluation Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

business reason

Study Start Date

April 23, 2018 (Actual)

Primary Completion Date

November 18, 2020 (Actual)

Study Completion Date

November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Olympus Corporation of the Americas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Lung Cancer Metastatic

Keywords

Electrosurgery, RF ablation, Minimally invasive, Lung cancer, Lung metastasis, Lung tumor, Primary, Metastatic, Endobronchial ultrasound, EBUS

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RF Ablation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

RF Ablation

Intervention Description

The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.

Primary Outcome Measure Information:

Title

ANET Related Peri-procedural Adverse Events

Description

The incidence of reported adverse events and serious adverse events related to the ANET device or procedure

Time Frame

Day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor Pathological proof of target nodule/tumor type and malignancy Target nodule/tumor which can be accessed via EBUS bronchoscopy Resection/surgical candidate Participants must be at least 18 years old and able to provide consent Exclusion criteria: Subjects in whom flexible bronchoscopy is contraindicated Target nodule < 1.0 cm Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives Pacemaker, implantable cardioverter, or other electronic implantable device

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

UT MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

12. IPD Sharing Statement

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ANET Electrosurgery Applicator Pilot Evaluation Study

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