TerminatedNot Applicable

ANET Electrosurgery Applicator Pilot Evaluation Study

Stopped: business reason

United States, Canada6 participantsStarted 2018-04-23

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

ANET Related Peri-procedural Adverse Events

Timeframe: Day 0

Trial details

NCT IDNCT03400748

SponsorOlympus Corporation of the Americas

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-18

Results submitted2021-06-25

View on ClinicalTrials.gov More Lung Cancer trials