Ureter Injury
Conditions
Brief summary
This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
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.
Interventions
DRUGIS-001
Intravenous injection of IS-001 investigational drug
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female subjects between the ages of 18 and 75, inclusive 2. 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
1. Subject is pregnant or nursing 2. Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Subject has any of the following screening laboratory values: 1. eGFR \< 60 mL/min/1.73 m\^2 2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN 3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN 4. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months 5. 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 6. Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| Safety Adverse Events Monitoring | 14 days post surgery | Drug related adverse events monitoring through 14-days |
| Incidence of abnormal blood work in tests results | Before same-day discharge or 24 hours after first IS-001 injection post surgery | Safety hematology complete blood count laboratory assessments Change from Baseline |
| Incidence of abnormal urinalysis results | 14 days post surgery | Routine urinalysis laboratory assessment change from baseline |
| Safety 12-Lead EKG Change from Baseline | 6 hours after first IS-001 injection post surgery | 12-Lead EKG change from baseline in QTc |
Countries
United States
Outcome results
None listed