ANET Electrosurgery Applicator Pilot Evaluation Study

Lung Cancer Clinical Trial

Official title:

ANET Electrosurgery Applicator Pilot Evaluation Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03400748
• Other study ID #: 15
• Status: Terminated
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: November 18, 2020

Study information

• Verified date: April 2024
• Source: Olympus Corporation of the Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Cancer Metastatic
• Lung Neoplasms

Intervention

Device:
• RF Ablation
The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Corporation of the Americas

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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