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IS-001 for Preventing Ureter Injury During Colorectal Surgery

Sunnyvale, CA
Phase 2
Waitlist Available
Led By Laila Rashidi, MD
Research Sponsored by Intuitive Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after second is-001 injection during surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if injecting IS-001 into the bloodstream can help surgeons see the ureter better during pelvic and abdominal surgeries, making these procedures safer. The fluorescent imaging agent IS-001 was well tolerated by all participants and has the potential to improve ureter visualization during minimally invasive hysterectomy procedures.

Who is the study for?
This trial is for men and women aged 18-75 who are scheduled for robotic-assisted surgery on the rectal, sigmoid, or left colon using da Vinci Surgical System with Firefly Imaging. Participants must have normal kidney function (eGFR ≥60) and liver enzymes within acceptable limits. Excluded are those in other drug/device studies, pregnant/nursing individuals, people with hepatitis B/C, or known hypersensitivity to indocyanine green.
What is being tested?
The study tests the safety and practicality of IS-001 injection as a help to see ureter structures better during robotic colorectal surgeries. It's given intravenously and observed for its effectiveness in making these structures clear to surgeons.
What are the potential side effects?
While specific side effects of IS-001 aren't listed here, common risks may include allergic reactions due to sensitivity to components like indocyanine green used in the formulation or potential issues related to intravenous injections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after second is-001 injection during surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after second is-001 injection during surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate ureter visualization by Independent Reader
Secondary study objectives
Evaluate fluorescent intensity of ureter by signal to background analysis
Evaluate ureter visualization by Intra-operative surgeon
Incidence of abnormal blood work in tests results
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Single Arm Safety and Feasibility Study of IS-001 with 20 mg in Multiple Injections
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IS-001
2016
Completed Phase 2
~130

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for ureter injuries include the use of contrast agents, surgical interventions, and stenting. Contrast agents, like IS-001, are injected intravenously to enhance the visualization of the ureter during imaging procedures, allowing for precise identification and assessment of the injury. This is crucial for planning appropriate surgical or non-surgical interventions. Surgical treatments, such as ureteroureterostomy, involve repairing the damaged section of the ureter, while stenting involves placing a tube to keep the ureter open and ensure proper urine flow. These treatments are essential for preventing complications such as obstruction, infection, and loss of kidney function.
Feasibility of Antegrade Contrast-enhanced US Nephrostograms to Evaluate Ureteral Patency.Hand-assisted laparoscopic ureteroureterostomy with renal mobilization for delayed recognition of a proximal ureteral injury after lumbar disk surgery.

Find a Location

Closest Location:Intuitive Surgical· Sunnyvale, CA

Who is running the clinical trial?

Intuitive SurgicalLead Sponsor
77 Previous Clinical Trials
50,498 Total Patients Enrolled
2 Trials studying Ureter Injury
331 Patients Enrolled for Ureter Injury
Laila Rashidi, MDPrincipal InvestigatorMultiCare Tacoma General Hospital
Thiru Lakshman, MDPrincipal InvestigatorSt. David's North Austin Medical Center
Peter Caravella, MDPrincipal InvestigatorValley Hospital Medical Center

Media Library

Single Arm Clinical Trial Eligibility Overview. Trial Name: NCT05769257 — Phase 2
Ureter Injury Research Study Groups: Single Arm
Ureter Injury Clinical Trial 2023: Single Arm Highlights & Side Effects. Trial Name: NCT05769257 — Phase 2
Single Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05769257 — Phase 2
~5 spots leftby Dec 2025