IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery

Phase 3Not Yet RecruitingNCT07346066

Intuitive Surgical146 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

146

Conditions

Ureter Injury

Interventions

filricianineDRUG

IV injection of IS-001 filricianine with near infrared (NIR) imaging

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female participants between the ages of 16 and 75, inclusive 2. 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 2. Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Participant has any of the following screening laboratory values: eGFR \< 30 mL/min/1.73 m2 1. Aspartate aminotransferase (AST) ≥ 2.5 × ULN 2. Alanine aminotransferase (ALT) ≥ 2.5 × ULN 3. Total Bilirubin \> 2mg/dL 4. Participant has any concomitant non-colorectal cancer 5. Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study 6. Participants have already been enrolled in another investigational drug or device study within the past 6 months 7. Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used 8. 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 9. The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.

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.

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.

Time frame: 10 minutes after first injection

Secondary Outcomes

Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length

Evaluate ureter length delineation at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the first IS-001 injection

Time frame: 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

Evaluate ureter visualization by each independent reader at (a) PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the second IS-001 injection

Time frame: 30 miinutes after second injection

Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length

Evaluate ureter length delineation at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the second IS-001 injection

Time frame: 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

Evaluate ureter visualization based on the intra-operative surgeon's rating at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the first IS-001 injection

Central Contacts

Clinical Project Manager

CONTACT

4085232100 info.is-001@intusurg.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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.

Evaluate ureter visualization by each independent reader at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 45 minutes after the first and second IS-001injection

Time frame: 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

Evaluate ureter visualization by each independent reader at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 45 minutes after the first and second IS-001injection

Time frame: 45 minutes after second injection

Concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

Time frame: 10 minutes after first injection

Concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

Time frame: 30 minutes after first injection

Concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

Time frame: 45 minutes after first injection

Concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

Time frame: 10 minutes after second injection

Concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

Time frame: 30 minutes after second injection

Concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

Time frame: 45 minutes after second injection

Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

Time frame: 10 minutes after first injection

Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

Time frame: 30 minutes after first injection

Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

Time frame: 45 minutes after first injection

Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

Time frame: 10 minutes after second injection

Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

Time frame: 30 minutes after second injection

Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

Time frame: 45 minutes after second injection

Degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

Time frame: 10 minutes after first injection

Degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

Time frame: 30 minutes after first injection

Degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

Time frame: 45 minutes after first injection

Degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

Time frame: 10 minutes after second injection

Degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

Time frame: 30 minutes after second injection

Degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

Time frame: 45 minutes after second injection