IS-001 for Ureter Injury
Recruiting at 8 trial locations
KH
Overseen ByKaren Hwang
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Intuitive Surgical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinator or your doctor for guidance.
Eligibility Criteria
This trial is for women aged 18-75 who are scheduled for robotic-assisted gynecological surgery using the da Vinci system with Firefly imaging. Participants must be able to consent.Inclusion Criteria
I am a woman aged between 18 and 75.
Subject is willing and able to provide informed consent.
I am scheduled for a robotic gynecological surgery using da Vinci with Firefly imaging.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single intravenous injection of IS-001 to aid in ureter visualization during robotic-assisted gynecological surgery
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the IS-001 injection and surgery
4 weeks
Treatment Details
Interventions
- IS-001
Trial Overview The study tests the safety and effectiveness of IS-001, an intravenous injection intended to help surgeons see ureter structures better during operation.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EfficacyExperimental Treatment1 Intervention
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.
IS-001 is already approved in United States for the following indications:
Approved in United States as IS-001 for:
- Ureteral Diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intuitive Surgical
Lead Sponsor
Trials
80
Recruited
49,600+
Gary Guthart
Intuitive Surgical
Chief Executive Officer since 2010
PhD in Engineering, California Institute of Technology
Henry Charlton
Intuitive Surgical
Chief Medical Officer since 2023
MD from an unspecified institution
Findings from Research
In a study of 39,405 surgeries conducted over 13 years, ureteral injury occurred in 32 cases, resulting in an incidence rate of 0.04%, primarily associated with gynecological hysterectomies.
The most common type of ureteral injury was ligation in the distal third, and the majority of repairs were successfully managed through ureteral reimplantation, indicating effective surgical intervention for this complication.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Ureteral injury at the National Institute of Perinatology].Meraz Avila, D., Rodríguez Colorado, S., Ramírez Isarraraz, C., et al.[2007]
Iatrogenic ureteric injury (IUI) is a common and serious complication of major abdominal and pelvic surgeries, leading to significant health risks due to its potential for high morbidity and mortality.
The paper emphasizes the importance of timely diagnosis of IUI, proposing a specific imaging protocol to improve detection and follow-up, which is crucial given the non-specific symptoms associated with this type of injury.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Suspected iatrogenic ureteric injury: an approach to diagnostic imaging.Briggs, JH., Wing, L., Macdonald, AC., et al.[2015]
Using a safety wire (SW) during the insertion of ureteral access sheaths (UAS) significantly increased the average and maximum insertion forces compared to not using a SW, with mean forces of 1.79 kg vs 0.67 kg respectively.
Despite the increased insertion force with the SW, there was no significant difference in the total number or severity of ureteral lacerations between the SW and no SW groups, indicating that the SW does not impact the risk of ureteral injury.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The effect of extralumenal safety wires on ureteral injury and insertion force of ureteral access sheaths: evaluation using an ex vivo porcine model.Graversen, JA., Valderrama, OM., Korets, R., et al.[2012]
References
[Ureteral injury at the National Institute of Perinatology]. [2007]
Suspected iatrogenic ureteric injury: an approach to diagnostic imaging. [2015]
The effect of extralumenal safety wires on ureteral injury and insertion force of ureteral access sheaths: evaluation using an ex vivo porcine model. [2012]
Frequency of lower urinary tract injury after gastrointestinal surgery in the nationwide inpatient sample database. [2022]
Intraoperative ureter visualization using a near-infrared imaging agent. [2020]
Other People Viewed
By Subject
By Trial
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.