Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05954767 | IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery | PHASE3 | COMPLETED | 189 | — | — | Jan 17, 2024 | Sep 29, 2025 | Jan 15, 2026 | 8 | United States |
| NCT05769257 | A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery | PHASE2 | COMPLETED | 12 | — | — | Jun 14, 2023 | Apr 4, 2024 | May 29, 2024 | 2 | United States |
| NCT03937505 | A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy | PHASE2 | COMPLETED | 94 | — | — | May 28, 2019 | Jul 22, 2021 | Aug 5, 2021 | 3 | United States |
Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection
Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible
Fluorescent intensity of ureter evaluated as signal to background
| Arm | Type | Description |
|---|---|---|
| Efficacy | OTHER | Single intravenous injection of IS-001 and ureter visualization and delineation will be compared in white light standard of care and near-infrared (NIR) imaging mode. |
| Single Arm | EXPERIMENTAL | Single Arm Safety and Feasibility Study of IS-001 with 20 mg in Multiple Injections |
| Dose-escalation | EXPERIMENTAL | Dose-cohort escalation of single intravenous injection of IS-001 starting with 20 mg (n=8), escalating in 20 mg increments until optimal dose is determined. |
| Optimal dose-characterization | EXPERIMENTAL | Single intravenous injection of IS-001 at the optimal dose will be administered to subjects assigned to the treatment group. Safety control subjects will not receive any study drug but will undergo robotic surgery and all associated safety assessment clinical trial procedures. |
| Name | Type | Description |
|---|---|---|
| IS-001 | DRUG | IV injection of IS-001 drug substance with near infrared (NIR) imaging |
| No treatment | DRUG | no drug injection |
Inclusion Criteria: 1. Female subject is between the ages of 16 and 75, inclusive at time of consent. 2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging. 3. Subject and/or subject's parent/guardian is will...