A Phase 3 interventional study of filricianine in Ureter Injury, sponsored by Intuitive Surgical. Recruiting at 9 sites in United States. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Intuitive Surgical · Phase 3, Interventional, and Prevention
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.
Intuitive Surgical is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
1. Participant is pregnant or nursing 2. Participant has known current acute or chronic virus (HBV) or virus (HCV) infection 3. Participant has any of the following screening laboratory values: \< 30 mL/min/1.73 m2
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: filricianine
IV injection of IS-001 filricianine with near infrared (NIR) imaging
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.
Time frame: 10 minutes after first 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 first IS-001 injection
Time frame: 30 minutes after the 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) PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the second IS-001 injection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 45 minutes after second injection
Plan to share: No
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Started May 2026 (actual). Primary completion is estimated for Apr 2027, 11 months after the start.
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