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IS-001 · 4 trials · 3 indications
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
Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events
| 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. |
| IV IS-001 drug | EXPERIMENTAL | IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System |
| Name | Type | Description |
|---|---|---|
| IS-001 | DRUG | IV injection of IS-001 drug substance with near infrared (NIR) imaging |
| No treatment | DRUG | no drug injection |
| da Vinci® Si/Xi Surgical System | DEVICE | robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging |
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...
IS-001 is an investigational small molecule being studied for use in hysterectomy and for the prevention or treatment of ureter injury during surgery. Clinical trials have evaluated it in patients undergoing robotic hysterectomy, robotic colorectal surgery, and robotic-assisted gynecological surgery.
IS-001 is being developed by Intuitive Surgical, Inc., a company traded on the Nasdaq under the ticker ISRG. The company has sponsored multiple clinical trials of IS-001 in the United States.
IS-001 is in clinical development. While early trials were Phase 1 and Phase 2, the most advanced completed trial is a Phase 3 study in patients undergoing robotic-assisted gynecological surgery. IS-001 is investigational and has not been approved by the FDA.
IS-001 has been studied in four completed trials: NCT03006237 (Phase 1 safety and pharmacokinetics), NCT03937505 (Phase 2 in robotic hysterectomy), NCT05769257 (Phase 2 in robotic colorectal surgery), and NCT05954767 (Phase 3 in robotic-assisted gynecological surgery). All trials were conducted in the United States.
IS-001 is a small molecule, but its specific molecular target has not been disclosed. Clinical trials have focused on its safety, tolerability, pharmacokinetics, and efficacy in preventing ureter injury during robotic surgeries.