Clinical trial NCT05769257: A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ureter Injury
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates the safety and feasibility 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 feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate ureter visualization by Independent Reader
timeFrame: 10 minutes after first IS-001 injection during surgery
measure: Evaluate ureter visualization by Independent Reader
timeFrame: 30 minutes after first IS-001 injection during surgery
measure: Evaluate ureter visualization by Independent Reader
timeFrame: 45 minutes after first IS-001 injection during surgery
measure: Evaluate ureter visualization by Independent Reader
timeFrame: 10 minutes after second IS-001 injection during surgery
measure: Evaluate ureter visualization by Independent Reader
timeFrame: 30 minutes after second IS-001 injection during surgery
measure: Evaluate ureter visualization by Independent Reader
timeFrame: 45 minutes after second IS-001 injection during surgery
Secondary outcomes:
measure: Evaluate ureter visualization by Intra-operative surgeon
timeFrame: 10 minutes after first IS-001 injection during surgery
measure: Evaluate ureter visualization by Intra-operative surgeon
timeFrame: 30 minutes after first IS-001 injection during surgery
measure: Evaluate ureter visualization by Intra-operative surgeon
timeFrame: 45 minutes after first IS-001 injection during surgery
measure: Evaluate ureter visualization by Intra-operative surgeon
timeFrame: 10 minutes after second IS-001 injection during surgery
measure: Evaluate ureter visualization by Intra-operative surgeon
timeFrame: 30 minutes after second IS-001 injection during surgery
measure: Evaluate ureter visualization by Intra-operative surgeon
timeFrame: 45 minutes after second IS-001 injection during surgery
measure: Ureter Delineation Efficacy as Length of Line Drawn
timeFrame: 10 minutes after first IS-001 injection during surgery
measure: Ureter Delineation Efficacy as Length of Line Drawn
timeFrame: 30 minutes after first IS-001 injection during surgery
measure: Ureter Delineation Efficacy as Length of Line Drawn
timeFrame: 45 minutes after first IS-001 injection during surgery
measure: Ureter Delineation Efficacy as Length of Line Drawn
timeFrame: 10 minutes after second IS-001 injection during surgery
measure: Ureter Delineation Efficacy as Length of Line Drawn
timeFrame: 30 minutes after second IS-001 injection during surgery
measure: Ureter Delineation Efficacy as Length of Line Drawn
timeFrame: 45 minutes after second IS-001 injection during surgery
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 10 minutes after first IS-001 injection during surgery
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 30 minutes after first IS-001 injection during surgery
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 45 minutes after first IS-001 injection during surgery
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 10 minutes after second IS-001 injection during surgery
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 30 minutes after second IS-001 injection during surgery
measure: Evaluate fluorescent intensity of ureter by signal to background analysis
timeFrame: 45 minutes after second IS-001 injection during surgery
measure: Safety 12-Lead EKG Change from Baseline
timeFrame: 6 hours after first IS-001 injection post surgery
measure: Incidence of abnormal blood work in tests results
timeFrame: Before same-day discharge or 24 hours after first IS-001 injection post surgery
measure: Incidence of abnormal blood work in tests results
timeFrame: Before same-day discharge or 24 hours after first IS-001 injection post surgery
measure: Incidence of abnormal blood work in tests results
timeFrame: 14 days post surgery
measure: Incidence of abnormal blood work in tests results
timeFrame: 14 days post surgery
measure: Incidence of abnormal urinalysis results
timeFrame: 14 days post surgery
measure: Safety Adverse Events Monitoring
timeFrame: 14 days post surgery
Other outcomes:
Locations:
city: Austin
country: United States
facility: St. David's North Austin Medical Center
state: Texas
city: Tacoma
country: United States
facility: MultiCare Tacoma General Hospital
state: Washington
Study officials:
affiliation: St. David's North Austin Medical Center
name: Thiru Lakshman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MultiCare Tacoma General Hospital
name: Laila Rashidi, MD
role: PRINCIPAL_INVESTIGATOR
References: