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Synapse 3D With Intravascular Indocyanine Green

StatusRecruiting
PhasePhase 1/2
Started
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Record status
This record was last updated February 2, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Sep 30, 2025 to Sep 30, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v14
  2. Primary completion date: Sep 30, 2024 to Sep 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v13
  3. Primary completion date: Sep 30, 2023 to Sep 30, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v12
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2023 to Dec 1, 2022
    • Site details revised
    v11
  5. Start date: Sep 1, 2022 to Jan 1, 2023v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Dec 31, 2022 to Sep 30, 2023
    • Start date: May 1, 2022 to Sep 1, 2022
    • Study completion date: Jan 31, 2023 to Dec 31, 2023
    v9
  2. Start date: Feb 1, 2022 to May 1, 2022v8
  3. Start date: Jan 1, 2022 to Feb 1, 2022
    • Interventions: IC-Green (ICG) (Drug), VisiblePatient™ 3D Lung Modelling (Device) to IC-Green (ICG) (Drug), Synapse 3D Lung Modelling (Device)
    • Study description revised
    • Study title revised
    v7
  4. Primary completion date: Sep 1, 2021 to Dec 31, 2022
    • Start date: Mar 1, 2021 to Jan 1, 2022
    • Study completion date: Sep 1, 2022 to Jan 31, 2023
    v6
  5. Start date: Sep 1, 2020 to Mar 1, 2021v5
  6. Primary completion date: Dec 31, 2020 to Sep 1, 2021
    • Start date: May 1, 2020 to Sep 1, 2020
    • Study completion date: Dec 31, 2021 to Sep 1, 2022
    v4
  7. Start date: Jan 1, 2020 to May 1, 2020v3
  8. Start date: Aug 1, 2019 to Jan 1, 2020
    • Primary completion date: Aug 1, 2020 to Dec 31, 2020
    • Study completion date: Aug 1, 2021 to Dec 31, 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 from this operation every year.
Trial Details
NCT Number NCT03953144
Lead Sponsor St. Joseph's Healthcare Hamilton
Conditions
(from sponsor)		 Non-small Cell Lung Cancer, Primary Neoplasm
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov