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Synapse 3D With Intravascular Indocyanine Green

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllSt. Joseph's Healthcare Hamilton
NCT03953144 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit

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📋 Eligibility rules (as published)
Inclusion Criteria: * Tumour size \<3 cm * Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC) * CT-imaging confirming that the tumour is confined to one broncho-pulmonary segment, rendering the patient a candidate for segmental resection. Exclusion Criteria: * Hypersensitivity or allergy to ICG, sodium iodide, or iodine * Women who are currently pregnant or breastfeeding; or women of childbearing potential who are not currently taking adequate birth control. * Patients with clinical evidence of N1 or N2 disease on preoperative imaging * Pulmonary Function tests demonstrating Forced Expiratory Volume in 1s (FEV1) or diffusion capacity of the lung for carbon monoxide (DLCO) less than or equal to 30% of predicted.
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What it tests

  • Synapse 3D Lung Modelling
  • IC-Green (ICG)
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Where

1 site
St. Josephs Healthcare Hamilton
Hamilton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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