Ureter Injury
Conditions
Keywords
robotic-assisted surgery, minimally invasive surgery
Brief summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.
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 efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging. Stage A will be a dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug safety control to evaluate the effects of surgery alone on the safety parameters of the study.
Interventions
DRUGIS-001
intravenous injection of IS-001 investigational drug
DRUGNo treatment
no drug injection
Sponsors
Intuitive Surgical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Stage A is a dose-cohort escalation to determine optimal efficacious dose, Stage B is an expanded safety and efficacy evaluation of the optimal dose with a no-drug safety control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female subject is between the ages of 18 and 75, inclusive 2. Subject is scheduled to undergo robotic gynecological surgery using a da Vinci® surgical system with Firefly® fluorescent imaging 3. Subject is willing and able to provide informed consent 4. Subject is considered capable of complying with study procedures
Exclusion criteria
1. Subject is pregnant or nursing 2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 4\. Subject is already enrolled in another investigational study 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate fluorescent intensity of ureter by signal to background analysis | 10 minutes | Fluorescent intensity of ureter evaluated as signal to background |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of abnormal blood work in tests results | 24 hours | Safety hematology complete blood count laboratory assessments Change from Baseline |
| Incidence of abnormal urinalysis results | 14 days | Routine urinalysis laboratory assessment change from baseline |
| Safety Adverse Events Monitoring | 14 days | Drug related adverse events monitoring through 14-days |
| Pharmacokinetics Maximal Concentration (Cmax) of Drug Plasma Levels | 0, 1-2 hours and 2-3 hours | Maximal concentration of investigational drug-plasma levels (Cmax) |
| Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero to Last Sampling (AUClast) | 0, 1-2 hours and 2-3 hours | Area under the plasma curve from t(0) to last plasma sample |
| Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUCinf) | 0, 1-2 hours and 2-3 hours | Area under the plasma curve from t(0) extrapolated to infinity |
| Pharmacokinetics Drug Plasma Clearance (CL) | 0, 1-2 hours and 2-3 hours | Clearance of the investigational drug from plasma |
| Safety 12-Lead EKG Change from Baseline | 6 hours | 12-Lead EKG change from baseline in QTc |
| Pharmacokinetics Apparent Volume of Distribution (Vz) | 0, 1-2 hours and 2-3 hours | The apparent volume of distribution of the investigational drug |
| Ureter Identification Efficacy on a Nominal Scale | 10 minutes | 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 nominal scale where 0=No and 1=Yes |
| Ureter Delineation Efficacy as Length of Line Drawn in Millimeters | 10 minutes | 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 | 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. |
| Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale | 10 minutes post-dose | Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions. |
| Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale | 10 minutes post-dose | Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points. |
| Pharmacokinetics Terminal Elimination Half-life (t1/2) | 0, 1-2 hours and 2-3 hours | Half-life of the investigational drug in plasma |
Countries
United States
Outcome results
None listed