NCT07793266 ICG Fluorescence in Knee Arthroscopy Study
| NCT ID | NCT07793266 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Henry Ford Health System |
| Condition | To Assess the Feasibility, Visualization Capability, and Optimal Dosing of ICG Fluorescence Imaging for Intraoperative Assessment of Knee Tissue Perfusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-06-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to first evaluate whether ICG fluorescence angiography can be used to evaluate blood flow of the anterior cruciate ligament (ACL), tendons, and knee structures during an arthroscopic surgery. The secondary purpose is to evaluate differences in the blood flow in patients with varying grades of ACL tears. To determine optimal intravenous dose of SPY Agent Green and time to visualize fluorescence in tendons and structures intraoperatively during arthroscopic surgery (if primary objective is deemed yes). We hypothesize that ICG will be effective in evaluating blood flow in patients undergoing knee arthroscopy.
Eligibility Criteria
Inclusion Criteria: Patients undergoing knee arthroscopy with a HFH Orthopaedic surgeon * Patients must be within ages of 14-89. Patient ages 14-17 will be included to capture an important sporting demographic who sustain ACL injuries which would stand to benefit from this intervention if successful. * Have signed an approved informed consent form for the study. * Be willing to comply with the protocol Exclusion Criteria: * Patient is less than 14 years of age or greater than 89 years of age * Patients who have had iodide-based radiology studies within the last seven (7) days prior to surgery * Previous surgical repair of targeted surgical area * Known allergy or history of adverse reaction to SPY Agent Green, ICG, * Subjects who have participated in another investigational study within 30 days prior to surgery. * Pregnant or lactating subjects. * Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigational procedure, or interfere with the interpretation of study results.
Contact & Investigator
Vasilios Moutzouros, MD
PRINCIPAL INVESTIGATOR
Henry Ford Health System
Frequently Asked Questions
Who can join the NCT07793266 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 89 Years, studying To Assess the Feasibility, Visualization Capability, and Optimal Dosing of ICG Fluorescence Imaging for Intraoperative Assessment of Knee Tissue Perfusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07793266 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07793266 currently recruiting?
Yes, NCT07793266 is actively recruiting participants. Contact the research team at mjani1@hfhs.org for enrollment information.
Where is the NCT07793266 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT07793266 clinical trial?
NCT07793266 is sponsored by Henry Ford Health System. The principal investigator is Vasilios Moutzouros, MD at Henry Ford Health System. The trial plans to enroll 40 participants.