Ureter InjuryPhase 3NCT07346066
IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
A Phase 3 study testing filricianine in people with Ureter Injury, run by Intuitive Surgical at 9 sites in United States.
Trial summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Ureter Injury
- What is being tested?
- filricianine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 May 2026to 31 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female participants between the ages of 16 and 75, inclusive
- 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
- Aspartate aminotransferase (AST) ≥ 2.5 × ULN
- Alanine aminotransferase (ALT) ≥ 2.5 × ULN
- 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.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
St David's North Austin Medical Center
Austin, Texas, 78758
Krishna Saini, 5125448070, Krishna.Saini@stdavids.com
Thiru Lakshman, MD
- Not yet recruiting
The Ohio State Unversity
Columbus, Ohio, 43210
Chandler Lowe, (614) 293-9955, chandler.lowe@osumc.edu
Emily Huang, MD
- Recruiting
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
Jimena Alcocer-Barrios, 713-527-5000, jalcocerbarrios@houstoncolon.com
Eric Haas, MD
- Not yet recruiting
Kettering Health
Kettering, Ohio, 45429
Clinical Research Coordinator, 855-500-2873
Minia Hellan, MD
- Recruiting
Mountain View Hospital
Las Vegas, Nevada, 89128
Coral Rodriguez, 702-255-5000, coral.rodriguez@hchealthcare.com
Garrett Friedman, MD
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Kyra Jersey, 203-688-4242, kyra.jersey@yale.edu
Haddon Pantel, MD
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Vianh Truong, 949-764-5597 ext. 45597, vianh.truong@hoag.org
Babak Rad, MD
- Recruiting
Orlando Health
Orlando, Florida, 32806
Patty Camacho, 321-842-4130, Patty.Camacho@orlandohealth.com
Marco Ferrara, MD
- Not yet recruiting
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
Stacey Macon, 253-403-0791, Stacey.Macon@multicare.org
Laila Rashidi, MD
About this study
Official title: A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Read the 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.
- Conditions
- Ureter Injury
- Being tested
- filricianine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filricianineDrug
IV injection of IS-001 filricianine with near infrared (NIR) imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: filricianine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes after first injection
Secondary outcomes (30)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 45 minutes after second injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start14 May 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter InjuryStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346066
- Sponsor's protocol ID
- ISI-124804-CR-3
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT07346066
- Acronym / sponsor ID
- ISI-124804-CR-3
- Conditions
- Ureter Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IS-001 Injection | Other | Drug: filricianineUreter 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female participants between the ages of 16 and 75, inclusive
- 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
- Aspartate aminotransferase (AST) ≥ 2.5 × ULN
- Alanine aminotransferase (ALT) ≥ 2.5 × ULN
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filricianineIV injection of IS-001 filricianine with near infrared (NIR) imaging | Drug | IS-001 Injection |
Primary outcome
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.
Time frame: 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.
30 secondary outcomes
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
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
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
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
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.
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
Time frame: 45 minutes after second injection
Concordance of ureter visualization between independent readers
Time frame: 10 minutes after first injection
Concordance of ureter visualization between independent readers
Time frame: 30 minutes after first injection
Concordance of ureter visualization between independent readers
Time frame: 45 minutes after first injection
Concordance of ureter visualization between independent readers
Time frame: 10 minutes after second injection
Concordance of ureter visualization between independent readers
Time frame: 30 minutes after second injection
Concordance of ureter visualization between independent readers
Time frame: 45 minutes after second injection
Concordance between intra-operative ureter visualization assessment and 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
Time frame: 30 minutes after first injection
Concordance between intra-operative ureter visualization assessment and 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
Time frame: 10 minutes after second injection
Concordance between intra-operative ureter visualization assessment and 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
Time frame: 45 minutes after second injection
Degree of concordance of ureter visualization within independent readers
Time frame: 10 minutes after first injection
Degree of concordance of ureter visualization within independent readers
Time frame: 30 minutes after first injection
Degree of concordance of ureter visualization within independent readers
Time frame: 45 minutes after first injection
Degree of concordance of ureter visualization within independent readers
Time frame: 10 minutes after second injection
Degree of concordance of ureter visualization within independent readers
Time frame: 30 minutes after second injection
Degree of concordance of ureter visualization within independent readers
Time frame: 45 minutes after second injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode
Time frame: 10 minutes after first injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode
Time frame: 30 minutes after first injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode
Time frame: 45 minutes after first injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode
Time frame: 10 minutes after second injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode
Time frame: 30 minutes after second injection
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode
Time frame: 45 minutes after second injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing filricianine in people with Ureter Injury, run by Intuitive Surgical at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (4085232100, info.is-001@intusurg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 10 minutes after first injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.