IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
ConditionUreter Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-75
SponsorIntuitive Surgical
About this trial
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Aspartate aminotransferase (AST) ≥ 2.5 × ULN
Alanine aminotransferase (ALT) ≥ 2.5 × ULN
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.
Trial design
Design model
Single group
Treatments tested in this trial
filricianine
DrugIV injection of IS-001 filricianine with near infrared (NIR) imaging
Treatment groups
146 Participants
are divided into 1 treatment groupGroup A: IS-001 InjectionOther 1 intervention
Trial outcomes
Primary outcomes
1
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 injectionSecondary outcomes
1
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 injection2
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 injection3
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 injection4
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
Time frame
30 minutes after first IS-001 injectionSponsors and contacts
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Source ClinicalTrials.gov