What side effects are associated with this type of intervention?

Common side effects of treatments for ureter injury involving contrast agents, like those studied in IS-001, include allergic reactions (ranging from mild rashes to severe anaphylaxis), nephrotoxicity leading to acute kidney injury, and delayed reactions such as nausea, vomiting, and headache. Localized reactions at the injection site, such as pain or swelling, may also occur.

What prior FDA approvals exist?

The FDA has approved several contrast agents for enhanced visualization in medical imaging, which can aid in the treatment of ureter injuries. These include gadolinium-based agents used in MRI and iodine-based agents used in CT scans. These contrast agents help in clearly delineating the ureteral structures, facilitating better diagnosis and surgical planning. While specific approvals for ureter injury treatments are not detailed, the use of these agents in imaging is crucial for managing such conditions.

What other types of research exist?

Promising alternatives to IS-001 for enhanced ureter visualization include non-ionic iodinated contrast agents like iopentol (Imagopaque) and Niopam 370, which have shown good safety and diagnostic efficacy. Additionally, advancements in MRI techniques, such as gadolinium-enhanced imaging, offer high-quality visualization with emerging techniques providing better staging and delineation of urinary structures.

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IS-001 for Preventing Ureter Injury During Colorectal Surgery

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 45 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 45 minutes after second is-001 injection during surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~45 minutes after second is-001 injection during surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 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

Do I qualify?Apply below to find out

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.