CompletedNot Applicable

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

United States691 participantsStarted 2019-12-10

Plain-language summary

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Over 21 years of age;
✓. Capable and willing to give informed consent;
✓. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
✓. Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy

Exclusion criteria

✕. Medical contraindication to bronchoscopy as assessed by the investigator
✕. Presence of uncorrectable bleeding disorders
✕. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
✕. Patients with the target lesion having endobronchial involvement seen on chest CT
✕. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
✕. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
✕. Uncontrolled or irreversible coagulopathy;
✕. Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;

What they're measuring

Incidence of device or procedure related complications

Timeframe: up to 7 days post procedure

Trial details

NCT IDNCT04182815

SponsorAuris Health, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Pulmonary Nodule trials