A Phase 2 interventional study of IS-001 in Ureter Injury, sponsored by Intuitive Surgical. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Intuitive Surgical · Phase 2, Interventional, and Prevention
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.
Intuitive Surgical is the lead sponsor of 62 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject has any of the following screening laboratory values:
Single Arm Safety and Feasibility Study of IS-001 with 20 mg in Multiple Injections
Drug: IS-001
Intravenous injection of IS-001 investigational drug
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
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
Plan to share: No
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Intuitive Surgical