IS-001 for Ureter Injury

Recruiting at 8 trial locations

Overseen By Karen Hwang

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Intuitive Surgical

Disqualifiers: Pregnancy, Hepatitis B/C, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

237 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new treatment called IS-001, a special imaging agent, helps doctors visualize ureter structures during surgery. This is important because it aims to make surgical procedures safer and more effective through advanced imaging. The trial involves a single injection of IS-001, and doctors will compare results using standard and near-infrared imaging. Women scheduled for robotic-assisted gynecological surgery with specific imaging equipment may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking medical advancement.

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 there any evidence suggesting that IS-001 is likely to be safe for humans?

Research has shown that IS-001 is generally safe for patients. Studies have found that this treatment helps surgeons see the ureter (the tube connecting the kidney to the bladder) more clearly during operations. In these studies, participants did not experience serious side effects from IS-001. The treatment was tested on many patients, and most did not encounter any major problems. This suggests that IS-001 is safe for use in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard options for ureter injury, which often involve surgical repair or stenting, IS-001 is unique because it employs a novel imaging approach. IS-001 enhances ureter visualization through near-infrared (NIR) imaging, potentially offering more precise injury assessment and guidance during procedures. Researchers are excited because this technique could significantly improve surgical outcomes by enabling better detection and delineation of ureter injuries, reducing the risk of complications.

What evidence suggests that IS-001 is effective for ureter injury?

Research has shown that IS-001, which participants in this trial will receive, enhances surgical safety by improving the visibility of the ureters. The ureters are tubes that carry urine from the kidneys to the bladder. One study found that injecting IS-001 helps surgeons see the ureters more clearly during operations using near-infrared imaging. This improved visibility makes it easier to avoid accidental damage. Early results suggest that this treatment is safe and effective for enhancing visibility during surgery. Consequently, IS-001 could be a valuable tool in preventing ureter injuries, which can occur in some surgeries. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Subject is willing and able to provide informed consent.

I am a woman aged between 18 and 75.

I am scheduled for a robotic gynecological surgery using da Vinci with Firefly imaging.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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.

IS-001 is already approved in United States for the following indications:

Approved in United States as IS-001 for:

• Ureteral Diseases

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6977010/

Intraoperative ureter visualization using a near-infrared ... This is a first-in-human study showing preliminary results that the drug is safe and effective during surgery for improved ureter visualization.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05954767

IS-001 Injection in Patients Undergoing Robotic-Assisted ... This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03937505

A Safety and Efficacy Study of IS-001 Injection in Patients ... This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11236861/

The role of ureteric indocyanine green fluorescence in ... Ureteric injury (UI) is a devastating complication in 0.2–7.6% of colorectal operations, with modern large cohorts finding injury rates ...

5. researchgate.net researchgate.net/figure/Ureter-near-infrared-fluorescence-following-IV-IS-001-injection-Intraoperative-white_fig2_333859562

Ureter near-infrared fluorescence following IV IS-001 ... The fluorescent imaging agent IS-001 was determined to be well tolerated in all subjects and has the potential to provide ureter visualization throughout ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05769257?term=NCT05769257%20&rank=1

A Safety and Feasibility Study of IS-001 Injection in ... This study seeks to evaluate the safety and feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery ...

7. newsscope.aagl.org newsscope.aagl.org/volume-35-issue-4/iso-001/

Robotics SIG Tech Update: IS-001 - NewsScope - AAGL Only about one-third of ureteral injuries are detected intraoperatively, leading to delayed diagnosis and treatment, frequently with deleterious ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155346502030323X

Fluorescence Imaging of the Ureter in Minimally Invasive ... Nerindocianine was well tolerated with visualization of the ureter demonstrated in 88.9% of the subjects through 90 minutes postdosing.