Ureter Injury
Conditions
Brief summary
This study evaluates the safety and efficacy 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 efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted colorectal surgery with the da Vinci® Surgical System and Firefly® imaging.
Interventions
DRUGfilricianine
IV injection of IS-001 filricianine with near infrared (NIR) imaging
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female participants between the ages of 16 and 75, inclusive 2. Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging
Exclusion criteria
1\. Participant is pregnant or nursing 2. Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Participant has any of the following screening laboratory values: eGFR \< 30 mL/min/1.73 m2 1. Aspartate aminotransferase (AST) ≥ 2.5 × ULN 2. Alanine aminotransferase (ALT) ≥ 2.5 × ULN 3. Total Bilirubin \> 2mg/dL 4. Participant has any concomitant non-colorectal cancer 5. Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study 6. Participants have already been enrolled in another investigational drug or device study within the past 6 months 7. Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used 8. Participant is expected to receive or has received other methods for ureter identification during the surgery (e.g., ureteral stent placement, illuminated catheters, retrograde ICG injections) before the administration of IS-001 9. The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible. | 10 minutes after first injection | Evaluate ureter visualization by each independent reader at (a) the pelvic brim (PB) and (b) Inferior Mesenteric Artery (IMA) locations in Sensitive Firefly (SFF) mode compared to white light mode up to 30 minutes after the first IS-001 injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length | 30 minutes after the first injection | Evaluate ureter length delineation at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the first IS-001 injection |
| Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible | 30 miinutes after second injection | Evaluate ureter visualization by each independent reader at (a) PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the second IS-001 injection |
| Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible | 30 minutes after first IS-001 injection | Evaluate ureter visualization based on the intra-operative surgeon's rating at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the first IS-001 injection |
| Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible. | 45 minutes after first injection | Evaluate ureter visualization by each independent reader at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 45 minutes after the first and second IS-001injection |
| Concordance of ureter visualization between independent readers | 10 minutes after first injection | Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location |
| Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment | 10 minutes after first injection | Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment |
| Degree of concordance of ureter visualization within independent readers | 10 minutes after first injection | Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location |
| Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode | 10 minutes after first injection | Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location |
Countries
United States
Contacts
CONTACTClinical Project Manager
Outcome results
None listed