ANET Electrosurgery Applicator Pilot Evaluation Study

NCT03400748 | Terminated Results DMC FDA Device

• 1 other identifier: 15
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 4

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.

Conditions

Lung Cancer; Lung Cancer Metastatic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RF Ablation

EXPERIMENTAL

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

Device: RF Ablation

Interventions

RF Ablation DEVICE

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

RF Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead

Study Sites (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Hyperthermia; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Neoplastic Processes; Pathologic Processes

Results Point of Contact

• Title: Lauri DeVore
• Organization: Spiration, Inc.

lauri.devore@olympus.com

425-636-5464

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: April 23, 2018
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: April 3, 2024
• Results First Posted: September 27, 2021

Record last verified: 2024-04

Locations

CA (1); US (3)