Ureter InjuryPhase 3NCT05954767
IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
A Phase 3 study testing IS-001 in people with Ureter Injury, run by Intuitive Surgical at 8 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, women only
- Conditions the study is for
- Ureter Injury
- What is being tested?
- IS-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Jan 2024to 29 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female subject is between the ages of 16 and 75, inclusive at time of consent.
- Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
- Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.
Who cannot join
- Subject is pregnant or nursing.
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
- 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
- Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
- Subject has any of the following screening laboratory values:
Show all 10Show fewer
- eGFR < 60 mL/min/1.73 m^2
- Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN
- Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.
- Planned use of CYTALUX™ (pafolacianine) for surgery
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
St. David's Surgical Hospital
Austin, Texas, 78681
The Ohio State Unversity
Columbus, Ohio, 43210
OhioHealth
Columbus, Ohio, 43214
E.W. Sparrow Hospital
Lansing, Michigan, 48912
MountainView Hospital
Las Vegas, Nevada, 89128
HCA Mercy Hospital
Miami, Florida, 33133
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Orlando Health
Orlando, Florida, 32806
About this study
Official title: A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent 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 surgery with the da Vinci® Surgical System and Firefly® imaging.
- Conditions
- Ureter Injury
- Being tested
- IS-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IS-001Drug
IV injection of IS-001 drug substance with near infrared (NIR) imaging
| Study group | Role | What they receive |
|---|---|---|
| Efficacy | Other | Single intravenous injection of IS-001 and ureter visualization and delineation will be compared in white light standard of care and near-infrared (NIR) imaging mode. Receives: Drug: IS-001 |
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 independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection
Measured: 10 minutes
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 independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection
Measured: 30 minutes
Secondary outcomes (19)
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after injection
Measured: 10
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after injection
Measured: 30
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 intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection
Measured: 10 minutes
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 intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection
Measured: 30 minutes
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 independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection
Measured: 45 minutes
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection
Measured: 45 minutes
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 intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection
Measured: 45 minutes
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.
Measured: 10 minutes
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.
Measured: 30 minutes
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.
Measured: 45 minutes
concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 10 minutes
concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 30 minutes
concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 45 minutes
Determine degree of concordance of ureter visualization between independent readers
Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 10 minutes
Determine degree of concordance of ureter visualization between independent readers
Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 30 minutes
Determine degree of concordance of ureter visualization between independent readers
Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 45 minutes
degree of concordance of ureter visualization within independent readers
Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 10 minutes
degree of concordance of ureter visualization within independent readers
Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 30 minutes
degree of concordance of ureter visualization within independent readers
Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start17 Jan 2024
- Primary completion31 Jan 2025
- Study completion29 Sep 2025
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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954767
- Sponsor's protocol ID
- ISI-124804-3
- Status last verified
- Sep 2025
- First submitted
- 1 Jun 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
- ClinicalTrials.gov ID
- NCT05954767
- Acronym / sponsor ID
- ISI-124804-3
- Conditions
- Ureter Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 20 Jul 2023 (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 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 |
|---|---|---|
| Efficacy | Other | Drug: IS-001Single intravenous injection of IS-001 and ureter visualization and delineation will be compared in white light standard of care and near-infrared (NIR) imaging mode. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female subject is between the ages of 16 and 75, inclusive at time of consent.
- Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
- Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.
Key exclusion criteria (10 listed)
- Subject is pregnant or nursing.
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
- 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
- Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
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 |
|---|---|---|
| IS-001IV injection of IS-001 drug substance with near infrared (NIR) imaging | Drug | Efficacy |
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
Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after 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: 30 minutes
Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection
19 secondary outcomes
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
Time frame: 10
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
Time frame: 30
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: 10 minutes
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
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
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
Time frame: 45 minutes
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: 45 minutes
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
Time frame: 10 minutes
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
Time frame: 30 minutes
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
Time frame: 45 minutes
concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
Time frame: 10 minutes
concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
Time frame: 30 minutes
concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
Time frame: 45 minutes
Determine degree of concordance of ureter visualization between independent readers
Time frame: 10 minutes
Determine degree of concordance of ureter visualization between independent readers
Time frame: 30 minutes
Determine degree of concordance of ureter visualization between independent readers
Time frame: 45 minutes
degree of concordance of ureter visualization within independent readers
Time frame: 10 minutes
degree of concordance of ureter visualization within independent readers
Time frame: 30 minutes
degree of concordance of ureter visualization within independent readers
Time frame: 45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 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 IS-001 in people with Ureter Injury, run by Intuitive Surgical at 8 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). The study lists 2 primary outcomes in all. 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 15 Jan 2026.