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Ureter InjuryPhase 2NCT05769257

A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery

A Phase 2 study testing IS-001 in people with Ureter Injury, run by Intuitive Surgical at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation Read more about this study

Who is it for?
Ages 18 to 75 years
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
12 participants
Where
2 sitesUnited States
Study dates
14 Jun 2023to 4 Apr 2024
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects between the ages of 18 and 75, inclusive
  • Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging

Who cannot join

  • Subject is pregnant or nursing
  • Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Subject has any of the following screening laboratory values:
  • eGFR < 60 mL/min/1.73 m^2
  • Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
  • Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
Show all 9Show fewer
  • 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
  • Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • St. David's North Austin Medical Center

    Austin, Texas, 78758

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: A Phase 2 Multi-Center Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

This study evaluates the safety and feasibility 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 feasibility 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

    Intravenous injection of IS-001 investigational drug

Study groups in NCT05769257
Study groupRoleWhat they receive
Single ArmExperimentalSingle Arm Safety and Feasibility Study of IS-001 with 20 mg in Multiple Injections
Receives: Drug: IS-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate ureter visualization by Independent Reader

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 10 minutes after first IS-001 injection during surgery

  2. Evaluate ureter visualization by Independent Reader

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 30 minutes after first IS-001 injection during surgery

  3. Evaluate ureter visualization by Independent Reader

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 45 minutes after first IS-001 injection during surgery

  4. Evaluate ureter visualization by Independent Reader

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 10 minutes after second IS-001 injection during surgery

  5. Evaluate ureter visualization by Independent Reader

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 30 minutes after second IS-001 injection during surgery

  6. Evaluate ureter visualization by Independent Reader

    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 45 minutes after second IS-001 injection during surgery

Secondary outcomes (25)

  1. Evaluate ureter visualization by Intra-operative surgeon

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 10 minutes after first IS-001 injection during surgery

  2. Evaluate ureter visualization by Intra-operative surgeon

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 30 minutes after first IS-001 injection during surgery

  3. Evaluate ureter visualization by Intra-operative surgeon

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 45 minutes after first IS-001 injection during surgery

  4. Evaluate ureter visualization by Intra-operative surgeon

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 10 minutes after second IS-001 injection during surgery

  5. Evaluate ureter visualization by Intra-operative surgeon

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 30 minutes after second IS-001 injection during surgery

  6. Evaluate ureter visualization by Intra-operative surgeon

    Intra-operative surgeon assessment of ureter visibility in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible

    Measured: 45 minutes after second IS-001 injection during surgery

  7. Ureter Delineation Efficacy as Length of Line Drawn

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

    Measured: 10 minutes after first IS-001 injection during surgery

  8. Ureter Delineation Efficacy as Length of Line Drawn

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

    Measured: 30 minutes after first IS-001 injection during surgery

  9. Ureter Delineation Efficacy as Length of Line Drawn

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

    Measured: 45 minutes after first IS-001 injection during surgery

  10. Ureter Delineation Efficacy as Length of Line Drawn

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

    Measured: 10 minutes after second IS-001 injection during surgery

  11. Ureter Delineation Efficacy as Length of Line Drawn

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

    Measured: 30 minutes after second IS-001 injection during surgery

  12. Ureter Delineation Efficacy as Length of Line Drawn

    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

    Measured: 45 minutes after second IS-001 injection during surgery

  13. Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    Measured: 10 minutes after first IS-001 injection during surgery

  14. Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    Measured: 30 minutes after first IS-001 injection during surgery

  15. Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    Measured: 45 minutes after first IS-001 injection during surgery

  16. Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    Measured: 10 minutes after second IS-001 injection during surgery

  17. Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    Measured: 30 minutes after second IS-001 injection during surgery

  18. Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    Measured: 45 minutes after second IS-001 injection during surgery

  19. Safety 12-Lead EKG Change from Baseline

    12-Lead EKG change from baseline in QTc

    Measured: 6 hours after first IS-001 injection post surgery

  20. Incidence of abnormal blood work in tests results

    Safety hematology complete blood count laboratory assessments Change from Baseline

    Measured: Before same-day discharge or 24 hours after first IS-001 injection post surgery

  21. Incidence of abnormal blood work in tests results

    Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline

    Measured: Before same-day discharge or 24 hours after first IS-001 injection post surgery

  22. Incidence of abnormal blood work in tests results

    Safety hematology complete blood count laboratory assessments Change from Baseline

    Measured: 14 days post surgery

  23. Incidence of abnormal blood work in tests results

    Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline

    Measured: 14 days post surgery

  24. Incidence of abnormal urinalysis results

    Routine urinalysis laboratory assessment change from baseline

    Measured: 14 days post surgery

  25. Safety Adverse Events Monitoring

    Drug related adverse events monitoring through 14-days

    Measured: 14 days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start14 Jun 2023
  3. Primary completion18 Mar 2024
  4. Study completion4 Apr 2024

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05769257
Sponsor's protocol ID
ISI-124804-CR-2
Status last verified
May 2024
First submitted
31 Jan 2023
Last updated
29 May 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IS-001 in people with Ureter Injury, run by Intuitive Surgical at 2 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 2 inclusion and 9 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Evaluate ureter visualization by Independent Reader (time frame: 10 minutes after first IS-001 injection during surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05769257.

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 29 May 2024.

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