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Study Arms (4)

2 mL of SPY Agent Green (5.0 mg dose)

EXPERIMENTAL

Cohort #1: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 2 mL of SPY Agent Green (5.0 mg dose)

Combination Product: Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose)

3 mL of SPY Agent Green (7.5 mg dose)

EXPERIMENTAL

Cohort #2: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 3 mL of SPY Agent Green (7.5 mg dose)

Combination Product: Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose)

4.0 mL of SPY Agent Green (10.0 mg dose)

EXPERIMENTAL

Interventions

Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose)Combination product

Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.

2 mL of SPY Agent Green (5.0 mg dose)

Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose)Combination product

Eligibility Criteria

Age14 Years - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

Study Design

Study Type

interventional

Phase

phase 1

Allocation

NON RANDOMIZED

Masking

NONE

Masking Details

The only think that will be masked to the patient is the dose of the ICG dye that is being administered.

Purpose

DIAGNOSTIC

Intervention Model

SEQUENTIAL

Model Details: Approximately 40 subjects will be enrolled at 1 center in North America. Dose cohorts have been identified based on previous pre-clinical work and clinical publications, however, during the study those cohorts may be modified by the company and PI to adjust based on image sensitivity or fluorescence signal, never to exceed maximum daily dose of SPY Agent Green at 2.0 mg / kg. Cohort #1: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 2 mL of SPY Agent Green (5.0 mg dose) Cohort #2: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 3 mL of SPY Agent Green (7.5 mg dose) Cohort #3: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 4.0 mL of SPY Agent Green (10.0 mg dose) Cohort #4: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 5.0 m

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Orthopedics-Sports Medicine

ICG Fluorescence in Knee Arthroscopy Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

2 mL of SPY Agent Green (5.0 mg dose)

3 mL of SPY Agent Green (7.5 mg dose)

4.0 mL of SPY Agent Green (10.0 mg dose)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

5.0 mL of SPY Agent Green (12.5 mg dose)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

2 mL of SPY Agent Green (5.0 mg dose)

3 mL of SPY Agent Green (7.5 mg dose)

4.0 mL of SPY Agent Green (10.0 mg dose)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

5.0 mL of SPY Agent Green (12.5 mg dose)

You may not qualify if:

Data Sharing

Source record

Locations