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This study evaluates the safety and efficacy 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IS-001 Injection | Other | Ureter visualization and delineation will be compared between white light (standard of care) and near-infrared (NIR) imaging mode after each of the two single intravenous injections of IS-001. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filricianine | Drug | IV injection of IS-001 filricianine with near infrared (NIR) imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 10 minutes after first injection |
| Measure | Description | Time Frame |
|---|---|---|
| Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length | 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 | 30 minutes after the first injection |
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Inclusion 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Contact | 4085232100 | info.is-001@intusurg.com |
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| 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 |
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 |
| 30 miinutes after second injection |
| Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length | 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 second IS-001 injection | 30 minutes after second 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 | 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 | 30 minutes after 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. | 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 | 45 minutes after first 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 | 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 | 45 minutes after second injection |
| Concordance of ureter visualization between independent readers | Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location | 10 minutes after first injection |
| Concordance of ureter visualization between independent readers | Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location | 30 minutes after first injection |
| Concordance of ureter visualization between independent readers | Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location | 45 minutes after first injection |
| Concordance of ureter visualization between independent readers | Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location | 10 minutes after second injection |
| Concordance of ureter visualization between independent readers | Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location | 30 minutes after second injection |
| Concordance of ureter visualization between independent readers | Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location | 45 minutes after second injection |
| Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment | Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment | 10 minutes after first injection |
| Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment | Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment | 30 minutes after first injection |
| Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment | Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment | 45 minutes after first injection |
| Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment | Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment | 10 minutes after second injection |
| Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment | Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment | 30 minutes after second injection |
| Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment | Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment | 45 minutes after second injection |
| Degree of concordance of ureter visualization within independent readers | Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location | 10 minutes after first injection |
| Degree of concordance of ureter visualization within independent readers | Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location | 30 minutes after first injection |
| Degree of concordance of ureter visualization within independent readers | Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location | 45 minutes after first injection |
| Degree of concordance of ureter visualization within independent readers | Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location | 10 minutes after second injection |
| Degree of concordance of ureter visualization within independent readers | Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location | 30 minutes after second injection |
| Degree of concordance of ureter visualization within independent readers | Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location | 45 minutes after second injection |
| Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode | Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location | 10 minutes after first injection |
| Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode | Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location | 30 minutes after first injection |
| Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode | Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location | 45 minutes after first injection |
| Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode | Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location | 10 minutes after second injection |
| Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode | Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location | 30 minutes after second injection |
| Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode | Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location | 45 minutes after second injection |