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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05769257
Other study ID # ISI-124804-CR-2
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 14, 2023
Est. completion date April 4, 2024

Study information

Verified date May 2024
Source Intuitive Surgical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 4, 2024
Est. primary completion date March 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
IS-001
Intravenous injection of IS-001 investigational drug

Locations

Country Name City State
United States St. David's North Austin Medical Center Austin Texas
United States MultiCare Tacoma General Hospital Tacoma Washington

Sponsors (1)

Lead Sponsor Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 10 minutes after first IS-001 injection during surgery
Primary 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 30 minutes after first IS-001 injection during surgery
Primary 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 45 minutes after first IS-001 injection during surgery
Primary 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 10 minutes after second IS-001 injection during surgery
Primary 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 30 minutes after second IS-001 injection during surgery
Primary 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 45 minutes after second IS-001 injection during surgery
Secondary 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 10 minutes after first IS-001 injection during surgery
Secondary 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 30 minutes after first IS-001 injection during surgery
Secondary 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 45 minutes after first IS-001 injection during surgery
Secondary 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 10 minutes after second IS-001 injection during surgery
Secondary 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 30 minutes after second IS-001 injection during surgery
Secondary 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 45 minutes after second IS-001 injection during surgery
Secondary 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. 10 minutes after first IS-001 injection during surgery
Secondary 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. 30 minutes after first IS-001 injection during surgery
Secondary 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. 45 minutes after first IS-001 injection during surgery
Secondary 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. 10 minutes after second IS-001 injection during surgery
Secondary 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. 30 minutes after second IS-001 injection during surgery
Secondary 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. 45 minutes after second IS-001 injection during surgery
Secondary Evaluate fluorescent intensity of ureter by signal to background analysis Fluorescent intensity of ureter evaluated as signal to background 10 minutes after first IS-001 injection during surgery
Secondary Evaluate fluorescent intensity of ureter by signal to background analysis Fluorescent intensity of ureter evaluated as signal to background 30 minutes after first IS-001 injection during surgery
Secondary Evaluate fluorescent intensity of ureter by signal to background analysis Fluorescent intensity of ureter evaluated as signal to background 45 minutes after first IS-001 injection during surgery
Secondary Evaluate fluorescent intensity of ureter by signal to background analysis Fluorescent intensity of ureter evaluated as signal to background 10 minutes after second IS-001 injection during surgery
Secondary Evaluate fluorescent intensity of ureter by signal to background analysis Fluorescent intensity of ureter evaluated as signal to background 30 minutes after second IS-001 injection during surgery
Secondary Evaluate fluorescent intensity of ureter by signal to background analysis Fluorescent intensity of ureter evaluated as signal to background 45 minutes after second IS-001 injection during surgery
Secondary Safety 12-Lead EKG Change from Baseline 12-Lead EKG change from baseline in QTc 6 hours after first IS-001 injection post surgery
Secondary Incidence of abnormal blood work in tests results Safety hematology complete blood count laboratory assessments Change from Baseline Before same-day discharge or 24 hours after first IS-001 injection post surgery
Secondary Incidence of abnormal blood work in tests results Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline Before same-day discharge or 24 hours after first IS-001 injection post surgery
Secondary Incidence of abnormal blood work in tests results Safety hematology complete blood count laboratory assessments Change from Baseline 14 days post surgery
Secondary Incidence of abnormal blood work in tests results Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline 14 days post surgery
Secondary Incidence of abnormal urinalysis results Routine urinalysis laboratory assessment change from baseline 14 days post surgery
Secondary Safety Adverse Events Monitoring Drug related adverse events monitoring through 14-days 14 days post surgery
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