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NCT04182815Completed

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

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors

Source: ClinicalTrials.gov · Last updated 28 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
691 (actual)
First submitted
26 Nov 2019
Start date
10 Dec 2019
Primary completion date
15 Dec 2023
Lead sponsor
Auris Health, Inc.
Diseases
Lung cancer
NCT number
NCT04182815

What you commit to

  • Study type: Observational
  • Participants enrolled: 691
  • From 10 Dec 2019 to the primary completion date, 15 Dec 2023
  • 19 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
  • 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;
  • CT scan done greater than 28 days before the bronchoscopy procedure.

Other illness

  • Presence of uncorrectable bleeding disorders

Other

  • Medical contraindication to bronchoscopy as assessed by the investigator
  • 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
  • Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
  • Uncontrolled or irreversible coagulopathy;

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Health Network
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TorontoCanadaUnknown status
Prince of Wales Hospital
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Hong KongChinaUnknown status
Clinical Research Associates of Central PA
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AltoonaUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
University of Chicago Medicine
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Costal Pulmonary Associates
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EncinitasUnited StatesUnknown status
University of Pittsburgh Medical Center, Hamot
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ErieUnited StatesUnknown status
The University of Connecticut Health Center
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FarmingtonUnited StatesUnknown status
Spectrum Health System
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Grand RapidsUnited StatesUnknown status
Franciscan Health Indianapolis
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IndianapolisUnited StatesUnknown status
Minnesota Lung Center, Ltd
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MinneapolisUnited StatesUnknown status
TriStar Centennial Medical center
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NashvilleUnited StatesUnknown status
Eisenhower Medical Center
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Rancho MirageUnited StatesUnknown status
Sarasota Memorial Hospital
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SarasotaUnited StatesUnknown status
Mayo Clinic - Arizona
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ScottsdaleUnited StatesUnknown status
Cancer Treatment Centers of America
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TulsaUnited StatesUnknown status
Northwestern Medicine Central DuPage Hospital
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WinfieldUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.