This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
12
Intravenous injection of IS-001 investigational drug
St. David's North Austin Medical Center
Austin, Texas, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
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
Time frame: 10 minutes after first IS-001 injection during surgery
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
Time frame: 30 minutes after first IS-001 injection during surgery
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
Time frame: 45 minutes after first IS-001 injection during surgery
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
Time frame: 10 minutes after second IS-001 injection during surgery
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
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Time frame: 30 minutes after second IS-001 injection during surgery
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
Time frame: 45 minutes after second IS-001 injection during surgery
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
Time frame: 10 minutes after first IS-001 injection during surgery
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
Time frame: 30 minutes after first IS-001 injection during surgery
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
Time frame: 45 minutes after first IS-001 injection during surgery
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
Time frame: 10 minutes after second IS-001 injection during surgery
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
Time frame: 30 minutes after second IS-001 injection during surgery
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
Time frame: 45 minutes after second IS-001 injection during surgery
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.
Time frame: 10 minutes after first IS-001 injection during surgery
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.
Time frame: 30 minutes after first IS-001 injection during surgery
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.
Time frame: 45 minutes after first IS-001 injection during surgery
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.
Time frame: 10 minutes after second IS-001 injection during surgery
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.
Time frame: 30 minutes after second IS-001 injection during surgery
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.
Time frame: 45 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 10 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 30 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 45 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 10 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 30 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 45 minutes after second IS-001 injection during surgery
Safety 12-Lead EKG Change from Baseline
12-Lead EKG change from baseline in QTc
Time frame: 6 hours after first IS-001 injection post surgery
Incidence of abnormal blood work in tests results
Safety hematology complete blood count laboratory assessments Change from Baseline
Time frame: Before same-day discharge or 24 hours after first IS-001 injection post surgery
Incidence of abnormal blood work in tests results
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
Time frame: Before same-day discharge or 24 hours after first IS-001 injection post surgery
Incidence of abnormal blood work in tests results
Safety hematology complete blood count laboratory assessments Change from Baseline
Time frame: 14 days post surgery
Incidence of abnormal blood work in tests results
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
Time frame: 14 days post surgery
Incidence of abnormal urinalysis results
Routine urinalysis laboratory assessment change from baseline
Time frame: 14 days post surgery
Safety Adverse Events Monitoring
Drug related adverse events monitoring through 14-days
Time frame: 14 days post surgery