Status:
TERMINATED
ANET Electrosurgery Applicator Pilot Evaluation Study
Lead Sponsor:
Olympus Corporation of the Americas
Conditions:
Lung Cancer
Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03400748
Start Date
April 23 2018
End Date
November 18 2020
Last Update
April 3 2024
Active Locations (4)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4