NCT07346066

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
16mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Aug 2027

First Submitted

Initial submission to the registry

January 14, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

January 14, 2026

Last Update Submit

January 14, 2026

Conditions

Ureter Injury

Outcome Measures

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.

    10 minutes after first injection

Secondary Outcomes (30)

  • 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

  • +25 more secondary outcomes

Study Arms (1)

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.

Drug: filricianine

Interventions

filricianineDRUG

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

IS-001 Injection

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female participants between the ages of 16 and 75, inclusive

You may not qualify if:

  • \. 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Clinical Project Manager

CONTACT

4085232100info.is-001@intusurg.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 16, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share