IS-001 for Ureter Injury

Recruiting at 8 trial locations

Overseen By Karen Hwang

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Intuitive Surgical

Disqualifiers: Pregnancy, Hepatitis B/C, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

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.

Is IS-001 safe for use in humans?

The fluorescent imaging agent IS-001 was found to be well tolerated and safe in all subjects during a study for ureter visualization in minimally invasive hysterectomy procedures. ^{1 2 3 4 5}

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.

Trial 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 (Procedure)

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

Group I: Efficacy Experimental Treatment 1 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.

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]

The overall rates of bladder and ureteral injuries during gastrointestinal surgeries were low, at 0.15% and 0.06% respectively, indicating that while these injuries are serious, they are relatively rare occurrences in this type of surgery.

Injuries were more common in open surgeries compared to laparoscopic procedures, and the presence of metastatic disease significantly increased the risk of these injuries, particularly during rectal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of lower urinary tract injury after gastrointestinal surgery in the nationwide inpatient sample database. Sawkar, HP., Kim, DY., Thum, DJ., et al.[2022]

The fluorescent imaging agent IS-001 was found to be well tolerated in all subjects, indicating its safety for use during minimally invasive hysterectomy procedures.

This first-in-human study suggests that IS-001 enhances ureter visualization when used with a near-infrared sensitive endoscope, potentially improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative ureter visualization using a near-infrared imaging agent. Farnam, RW., Arms, RG., Klaassen, AH., et al.[2020]

References

1. Mexico pubmed.ncbi.nlm.nih.gov

[Ureteral injury at the National Institute of Perinatology]. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Suspected iatrogenic ureteric injury: an approach to diagnostic imaging. [2015]

3. United States 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. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Frequency of lower urinary tract injury after gastrointestinal surgery in the nationwide inpatient sample database. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intraoperative ureter visualization using a near-infrared imaging agent. [2020]