A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery
Study Details
Study Description
Brief Summary
This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm 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
|
Outcome Measures
Primary Outcome Measures
- Evaluate ureter visualization by Independent Reader [10 minutes after first IS-001 injection during surgery]
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
- Evaluate ureter visualization by Independent Reader [30 minutes after first IS-001 injection during surgery]
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
- Evaluate ureter visualization by Independent Reader [45 minutes after first IS-001 injection during surgery]
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
- Evaluate ureter visualization by Independent Reader [10 minutes after second IS-001 injection during surgery]
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
- Evaluate ureter visualization by Independent Reader [30 minutes after second IS-001 injection during surgery]
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
- Evaluate ureter visualization by Independent Reader [45 minutes after second IS-001 injection during surgery]
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
Secondary Outcome Measures
- Evaluate ureter visualization by Intra-operative surgeon [10 minutes after first IS-001 injection during surgery]
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
- Evaluate ureter visualization by Intra-operative surgeon [30 minutes after first IS-001 injection during surgery]
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
- Evaluate ureter visualization by Intra-operative surgeon [45 minutes after first IS-001 injection during surgery]
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
- Evaluate ureter visualization by Intra-operative surgeon [10 minutes after second IS-001 injection during surgery]
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
- Evaluate ureter visualization by Intra-operative surgeon [30 minutes after second IS-001 injection during surgery]
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
- Evaluate ureter visualization by Intra-operative surgeon [45 minutes after second IS-001 injection during surgery]
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
- Ureter Delineation Efficacy as Length of Line Drawn [10 minutes after first IS-001 injection during surgery]
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.
- Ureter Delineation Efficacy as Length of Line Drawn [30 minutes after first IS-001 injection during surgery]
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.
- Ureter Delineation Efficacy as Length of Line Drawn [45 minutes after first IS-001 injection during surgery]
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.
- Ureter Delineation Efficacy as Length of Line Drawn [10 minutes after second IS-001 injection during surgery]
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.
- Ureter Delineation Efficacy as Length of Line Drawn [30 minutes after second IS-001 injection during surgery]
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.
- Ureter Delineation Efficacy as Length of Line Drawn [45 minutes after second IS-001 injection during surgery]
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.
- Evaluate fluorescent intensity of ureter by signal to background analysis [10 minutes after first IS-001 injection during surgery]
Fluorescent intensity of ureter evaluated as signal to background
- Evaluate fluorescent intensity of ureter by signal to background analysis [30 minutes after first IS-001 injection during surgery]
Fluorescent intensity of ureter evaluated as signal to background
- Evaluate fluorescent intensity of ureter by signal to background analysis [45 minutes after first IS-001 injection during surgery]
Fluorescent intensity of ureter evaluated as signal to background
- Evaluate fluorescent intensity of ureter by signal to background analysis [10 minutes after second IS-001 injection during surgery]
Fluorescent intensity of ureter evaluated as signal to background
- Evaluate fluorescent intensity of ureter by signal to background analysis [30 minutes after second IS-001 injection during surgery]
Fluorescent intensity of ureter evaluated as signal to background
- Evaluate fluorescent intensity of ureter by signal to background analysis [45 minutes after second IS-001 injection during surgery]
Fluorescent intensity of ureter evaluated as signal to background
- Safety 12-Lead EKG Change from Baseline [6 hours after first IS-001 injection post surgery]
12-Lead EKG change from baseline in QTc
- Incidence of abnormal blood work in tests results [24 hours after first IS-001 injection post surgery]
Safety hematology complete blood count laboratory assessments Change from Baseline
- Incidence of abnormal blood work in tests results [24 hours after first IS-001 injection post surgery]
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
- Incidence of abnormal blood work in tests results [14 days post surgery]
Safety hematology complete blood count laboratory assessments Change from Baseline
- Incidence of abnormal blood work in tests results [14 days post surgery]
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
- Incidence of abnormal urinalysis results [14 days post surgery]
Routine urinalysis laboratory assessment change from baseline
- Safety Adverse Events Monitoring [14 days post surgery]
Drug related adverse events monitoring through 14-days
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female subjects between the ages of 18 and 75, inclusive
-
Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging
Exclusion Criteria:
-
Subject is pregnant or nursing
-
Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
-
Subject has any of the following screening laboratory values:
-
eGFR < 60 mL/min/1.73 m^2
-
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
-
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
-
Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
-
Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
-
Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Intuitive Surgical | Sunnyvale | California | United States | 94086 |
Sponsors and Collaborators
- Intuitive Surgical
Investigators
- Principal Investigator: Thiru Lakshman, MD, St. David's North Austin Medical Center
- Principal Investigator: Peter Caravella, MD, Valley Hospital Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISI-124804-CR-2