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NCT03200704 · ClinicalTrials.gov registry record · Phase 3
A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
A Phase 3 study, sponsored by Novadaq Technologies ULC, now a part of Stryker.
- Completed
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
NCT03200704 is a Phase 3 study that has completed, run by Novadaq Technologies ULC, now a part of Stryker. The registered enrollment target is 152 participants.
The verdict
NCT03200704, a Phase 3 study, has completed, sponsored by Novadaq Technologies ULC, now a part of Stryker.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 152 participants
- Enrollment target
Study Summary
This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Technitium99m (Tc99m) and Gamma Probe.
Interventions
- COMBINATION_PRODUCT IC2000 and SPY-PHI
- COMBINATION_PRODUCT Tc-99m radioactive colloid and Gamma Probe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2019-01-04 |
| Est. Completion | 2020-09-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03200704
The ClinicalTrials.gov registry entry for NCT03200704 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novadaq Technologies ULC, now a part of Stryker, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IC2000 and SPY-PHI is the first listed.
NCT03200704 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03200704 about?
NCT03200704 is a clinical study titled "A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer". This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identificat...
What is the current status of trial NCT03200704?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2019-01-04. Estimated completion is 2020-09-28.
What interventions are being tested in trial NCT03200704?
The interventions under investigation include: IC2000 and SPY-PHI (COMBINATION_PRODUCT), Tc-99m radioactive colloid and Gamma Probe (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03200704?
This trial is sponsored by Novadaq Technologies ULC, now a part of Stryker, which has 4 total clinical trials registered on ClinicalTrials.gov.
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