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

May 28, 2024 updated by: Intuitive Surgical

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78758
        • St. David's North Austin Medical Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female subjects between the ages of 18 and 75, inclusive
  2. 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

Exclusion Criteria:

  1. Subject is pregnant or nursing
  2. Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

  3. Subject has any of the following screening laboratory values:

    1. eGFR < 60 mL/min/1.73 m^2
    2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
    3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
  4. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
  5. 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
  6. Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Arm
Single Arm Safety and Feasibility Study of IS-001 with 20 mg in Multiple Injections
Drug: IS-001
Intravenous injection of IS-001 investigational drug

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate ureter visualization by Independent Reader
Time Frame: 10 minutes after first IS-001 injection during surgery
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
10 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader
Time Frame: 30 minutes after first IS-001 injection during surgery
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
30 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader
Time Frame: 45 minutes after first IS-001 injection during surgery
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
45 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader
Time Frame: 10 minutes after second IS-001 injection during surgery
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
10 minutes after second IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader
Time Frame: 30 minutes after second IS-001 injection during surgery
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
30 minutes after second IS-001 injection during surgery
Evaluate ureter visualization by Independent Reader
Time Frame: 45 minutes after second IS-001 injection during surgery
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
45 minutes after second IS-001 injection during surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate ureter visualization by Intra-operative surgeon
Time Frame: 10 minutes after first IS-001 injection during surgery
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
10 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon
Time Frame: 30 minutes after first IS-001 injection during surgery
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
30 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon
Time Frame: 45 minutes after first IS-001 injection during surgery
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
45 minutes after first IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon
Time Frame: 10 minutes after second IS-001 injection during surgery
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
10 minutes after second IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon
Time Frame: 30 minutes after second IS-001 injection during surgery
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
30 minutes after second IS-001 injection during surgery
Evaluate ureter visualization by Intra-operative surgeon
Time Frame: 45 minutes after second IS-001 injection during surgery
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
45 minutes after second IS-001 injection during surgery
Ureter Delineation Efficacy as Length of Line Drawn
Time Frame: 10 minutes after first IS-001 injection during surgery
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.
10 minutes after first IS-001 injection during surgery
Ureter Delineation Efficacy as Length of Line Drawn
Time Frame: 30 minutes after first IS-001 injection during surgery
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.
30 minutes after first IS-001 injection during surgery
Ureter Delineation Efficacy as Length of Line Drawn
Time Frame: 45 minutes after first IS-001 injection during surgery
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.
45 minutes after first IS-001 injection during surgery
Ureter Delineation Efficacy as Length of Line Drawn
Time Frame: 10 minutes after second IS-001 injection during surgery
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.
10 minutes after second IS-001 injection during surgery
Ureter Delineation Efficacy as Length of Line Drawn
Time Frame: 30 minutes after second IS-001 injection during surgery
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.
30 minutes after second IS-001 injection during surgery
Ureter Delineation Efficacy as Length of Line Drawn
Time Frame: 45 minutes after second IS-001 injection during surgery
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.
45 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Time Frame: 10 minutes after first IS-001 injection during surgery
Fluorescent intensity of ureter evaluated as signal to background
10 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Time Frame: 30 minutes after first IS-001 injection during surgery
Fluorescent intensity of ureter evaluated as signal to background
30 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Time Frame: 45 minutes after first IS-001 injection during surgery
Fluorescent intensity of ureter evaluated as signal to background
45 minutes after first IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Time Frame: 10 minutes after second IS-001 injection during surgery
Fluorescent intensity of ureter evaluated as signal to background
10 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Time Frame: 30 minutes after second IS-001 injection during surgery
Fluorescent intensity of ureter evaluated as signal to background
30 minutes after second IS-001 injection during surgery
Evaluate fluorescent intensity of ureter by signal to background analysis
Time Frame: 45 minutes after second IS-001 injection during surgery
Fluorescent intensity of ureter evaluated as signal to background
45 minutes after second IS-001 injection during surgery
Safety 12-Lead EKG Change from Baseline
Time Frame: 6 hours after first IS-001 injection post surgery
12-Lead EKG change from baseline in QTc
6 hours after first IS-001 injection post surgery
Incidence of abnormal blood work in tests results
Time Frame: 14 days post surgery
Safety hematology complete blood count laboratory assessments Change from Baseline
14 days post surgery
Incidence of abnormal blood work in tests results
Time Frame: 14 days post surgery
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
14 days post surgery
Incidence of abnormal urinalysis results
Time Frame: 14 days post surgery
Routine urinalysis laboratory assessment change from baseline
14 days post surgery
Safety Adverse Events Monitoring
Time Frame: 14 days post surgery
Drug related adverse events monitoring through 14-days
14 days post surgery
Incidence of abnormal blood work in tests results
Time Frame: Before same-day discharge or 24 hours after first IS-001 injection post surgery
Safety hematology complete blood count laboratory assessments Change from Baseline
Before same-day discharge or 24 hours after first IS-001 injection post surgery
Incidence of abnormal blood work in tests results
Time Frame: Before same-day discharge or 24 hours after first IS-001 injection post surgery
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
Before same-day discharge or 24 hours after first IS-001 injection post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intuitive Surgical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thiru Lakshman, MD, St. David's North Austin Medical Center
  • Principal Investigator: Laila Rashidi, MD, MultiCare Tacoma General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISI-124804-CR-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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