NCT07346066RecruitingPhase 3
A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Intuitive Surgical
- Enrollment
- 146
- Locations
- 9
- Primary Endpoint
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.
Study Overview
Brief Summary
This study evaluates the safety and efficacy 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 efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted colorectal surgery with the da Vinci® Surgical System and Firefly® imaging.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female participants between the ages of 16 and 75, inclusive
- •Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging
Exclusion Criteria
- •1. Participant is pregnant or nursing
- •Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Participant has any of the following screening laboratory values: eGFR < 30 mL/min/1.73 m2
- •Aspartate aminotransferase (AST) ≥ 2.5 × ULN
- •Alanine aminotransferase (ALT) ≥ 2.5 × ULN
- •Total Bilirubin > 2mg/dL
- •Participant has any concomitant non-colorectal cancer
- •Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study
- •Participants have already been enrolled in another investigational drug or device study within the past 6 months
- •Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used
- •Participant is expected to receive or has received other methods for ureter identification during the surgery (e.g., ureteral stent placement, illuminated catheters, retrograde ICG injections) before the administration of IS-001
- •The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.
Arms & Interventions
IS-001 Injection
Other
Ureter visualization and delineation will be compared between white light (standard of care) and near-infrared (NIR) imaging mode after each of the two single intravenous injections of IS-001.
Intervention: filricianine (Drug)
Outcomes
Primary Outcomes
Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.
Time Frame: 10 minutes after first injection
Evaluate ureter visualization by each independent reader at (a) the pelvic brim (PB) and (b) Inferior Mesenteric Artery (IMA) locations in Sensitive Firefly (SFF) mode compared to white light mode up to 30 minutes after the first IS-001 injection.
Secondary Outcomes
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length(30 minutes after the first injection)
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible(30 miinutes after second injection)
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length(30 minutes after second injection)
- Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible(30 minutes after first IS-001 injection)
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.(45 minutes after first injection)
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible(45 minutes after second injection)
- Concordance of ureter visualization between independent readers(10 minutes after first injection)
- Concordance of ureter visualization between independent readers(30 minutes after first injection)
- Concordance of ureter visualization between independent readers(45 minutes after first injection)
- Concordance of ureter visualization between independent readers(10 minutes after second injection)
- Concordance of ureter visualization between independent readers(30 minutes after second injection)
- Concordance of ureter visualization between independent readers(45 minutes after second injection)
- Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(10 minutes after first injection)
- Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(30 minutes after first injection)
- Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(45 minutes after first injection)
- Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(10 minutes after second injection)
- Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(30 minutes after second injection)
- Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment(45 minutes after second injection)
- Degree of concordance of ureter visualization within independent readers(10 minutes after first injection)
- Degree of concordance of ureter visualization within independent readers(30 minutes after first injection)
- Degree of concordance of ureter visualization within independent readers(45 minutes after first injection)
- Degree of concordance of ureter visualization within independent readers(10 minutes after second injection)
- Degree of concordance of ureter visualization within independent readers(30 minutes after second injection)
- Degree of concordance of ureter visualization within independent readers(45 minutes after second injection)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode(10 minutes after first injection)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode(30 minutes after first injection)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode(45 minutes after first injection)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode(10 minutes after second injection)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode(30 minutes after second injection)
- Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode(45 minutes after second injection)
Investigators
Study Sites (9)
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