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

Ureter Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769257
• Other study ID #: ISI-124804-CR-2
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Ureter Injury

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