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IS-001 for Preventing Ureter Injury During Colorectal Surgery

Phase 2

Recruiting

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

Study Summary

This trial tests a new approach to help surgeons better identify the structures in the ureter during surgery.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate ureter visualization by Independent Reader

Secondary outcome measures

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

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

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Intuitive SurgicalLead Sponsor

73 Previous Clinical Trials

49,247 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for one to qualify as a participant in this research experiment?

"In order to be eligible for this clinical experiment, participants must have suffered damage to their ureter and fall into the age range between 18 and 75. As of right now, 12 individuals are taking part in the trial."

Answered by AI

Are any new candidates eligible for enrollment in this trial?

"Per the information found on clinicaltrials.gov, this research project has ceased its participant recruitment efforts. The original posting date for this trial was March 1st 2023 and it had a last update of March 13th 2023; however, there are still two other studies actively seeking volunteers at the moment."

Answered by AI

Does this research study admit individuals aged 18 and above?

"According to the eligibility requirements of this clinical trial, individuals aged 18-75 are encouraged to apply."

Answered by AI

Is the Single Arm protocol officially recognized by the FDA?

"According to our internal risk assessment, Single Arm's safety rating is 2. This reflects that while there is some clinical data supporting its safety, efficacy has yet to be established in a Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery

2023. "A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05769257.