Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Evaluate ureter visualization by Independent Reader |
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
10 minutes after first IS-001 injection during surgery |
|
Primary |
Evaluate ureter visualization by Independent Reader |
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
30 minutes after first IS-001 injection during surgery |
|
Primary |
Evaluate ureter visualization by Independent Reader |
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
45 minutes after first IS-001 injection during surgery |
|
Primary |
Evaluate ureter visualization by Independent Reader |
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
10 minutes after second IS-001 injection during surgery |
|
Primary |
Evaluate ureter visualization by Independent Reader |
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
30 minutes after second IS-001 injection during surgery |
|
Primary |
Evaluate ureter visualization by Independent Reader |
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
45 minutes after second IS-001 injection during surgery |
|
Secondary |
Evaluate ureter visualization by Intra-operative surgeon |
Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
10 minutes after first IS-001 injection during surgery |
|
Secondary |
Evaluate ureter visualization by Intra-operative surgeon |
Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
30 minutes after first IS-001 injection during surgery |
|
Secondary |
Evaluate ureter visualization by Intra-operative surgeon |
Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
45 minutes after first IS-001 injection during surgery |
|
Secondary |
Evaluate ureter visualization by Intra-operative surgeon |
Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
10 minutes after second IS-001 injection during surgery |
|
Secondary |
Evaluate ureter visualization by Intra-operative surgeon |
Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
30 minutes after second IS-001 injection during surgery |
|
Secondary |
Evaluate ureter visualization by Intra-operative surgeon |
Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible |
45 minutes after second IS-001 injection during surgery |
|
Secondary |
Ureter Delineation Efficacy as Length of Line Drawn |
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions. |
10 minutes after first IS-001 injection during surgery |
|
Secondary |
Ureter Delineation Efficacy as Length of Line Drawn |
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions. |
30 minutes after first IS-001 injection during surgery |
|
Secondary |
Ureter Delineation Efficacy as Length of Line Drawn |
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions. |
45 minutes after first IS-001 injection during surgery |
|
Secondary |
Ureter Delineation Efficacy as Length of Line Drawn |
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions. |
10 minutes after second IS-001 injection during surgery |
|
Secondary |
Ureter Delineation Efficacy as Length of Line Drawn |
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions. |
30 minutes after second IS-001 injection during surgery |
|
Secondary |
Ureter Delineation Efficacy as Length of Line Drawn |
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions. |
45 minutes after second IS-001 injection during surgery |
|
Secondary |
Evaluate fluorescent intensity of ureter by signal to background analysis |
Fluorescent intensity of ureter evaluated as signal to background |
10 minutes after first IS-001 injection during surgery |
|
Secondary |
Evaluate fluorescent intensity of ureter by signal to background analysis |
Fluorescent intensity of ureter evaluated as signal to background |
30 minutes after first IS-001 injection during surgery |
|
Secondary |
Evaluate fluorescent intensity of ureter by signal to background analysis |
Fluorescent intensity of ureter evaluated as signal to background |
45 minutes after first IS-001 injection during surgery |
|
Secondary |
Evaluate fluorescent intensity of ureter by signal to background analysis |
Fluorescent intensity of ureter evaluated as signal to background |
10 minutes after second IS-001 injection during surgery |
|
Secondary |
Evaluate fluorescent intensity of ureter by signal to background analysis |
Fluorescent intensity of ureter evaluated as signal to background |
30 minutes after second IS-001 injection during surgery |
|
Secondary |
Evaluate fluorescent intensity of ureter by signal to background analysis |
Fluorescent intensity of ureter evaluated as signal to background |
45 minutes after second IS-001 injection during surgery |
|
Secondary |
Safety 12-Lead EKG Change from Baseline |
12-Lead EKG change from baseline in QTc |
6 hours after first IS-001 injection post surgery |
|
Secondary |
Incidence of abnormal blood work in tests results |
Safety hematology complete blood count laboratory assessments Change from Baseline |
Before same-day discharge or 24 hours after first IS-001 injection post surgery |
|
Secondary |
Incidence of abnormal blood work in tests results |
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline |
Before same-day discharge or 24 hours after first IS-001 injection post surgery |
|
Secondary |
Incidence of abnormal blood work in tests results |
Safety hematology complete blood count laboratory assessments Change from Baseline |
14 days post surgery |
|
Secondary |
Incidence of abnormal blood work in tests results |
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline |
14 days post surgery |
|
Secondary |
Incidence of abnormal urinalysis results |
Routine urinalysis laboratory assessment change from baseline |
14 days post surgery |
|
Secondary |
Safety Adverse Events Monitoring |
Drug related adverse events monitoring through 14-days |
14 days post surgery |
|