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Adjusted LOA
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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 ureter injury and hysterectomy. It is also being evaluated in patients undergoing robotic colorectal surgery and robotic-assisted gynecological surgery. The drug is administered by injection and is intended to address surgical complications.
IS-001 is being developed by Intuitive Surgical, Inc., a company traded on NASDAQ under the ticker ISRG. Intuitive Surgical is known for its robotic-assisted surgical systems, and IS-001 is part of its pipeline of investigational therapies.
IS-001 has completed clinical trials in Phase 1, Phase 2, and Phase 3. The Phase 1 trial assessed safety, tolerance, and pharmacokinetics. Phase 2 trials evaluated safety and efficacy in robotic hysterectomy and feasibility in robotic colorectal surgery. A Phase 3 trial studied the drug in robotic-assisted gynecological surgery.
IS-001 has been studied in four completed clinical trials. NCT03006237 was a Phase 1 safety and pharmacokinetics study. NCT03937505 was a Phase 2 safety and efficacy study in robotic hysterectomy. NCT05769257 was a Phase 2 safety and feasibility study in robotic colorectal surgery. NCT05954767 was a Phase 3 study in robotic-assisted gynecological surgery.
IS-001 is an investigational drug and is not FDA approved. It has completed clinical trials, including a Phase 3 study, but approval status has not been established. The drug remains in clinical development and is not yet available for commercial use.
IS-001 is an investigational small molecule developed by Intuitive Surgical, Inc. It is administered by injection and is being studied for conditions related to ureter injury and hysterectomy. Clinical trials have evaluated its safety, efficacy, and feasibility in patients undergoing robotic-assisted surgical procedures.