Silicone vs Non-Silicone Stents for Kidney Stones

(BLUES Trial)

Recruiting at 12 trial locations

Overseen By Elaina Shoemaker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Anatomical anomalies, Urinary diversion, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 7 to 10 days

224 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a silicone stent works better for patients who have had surgery on their ureter. The silicone stent helps keep the ureter open so urine can flow easily. Silicone stents are generally better tolerated compared to other materials.

Research Team

Khurshid Ghani, MD, MS, FRCS

Principal Investigator

University of Michigan

Eligibility Criteria

The BLUES trial is for individuals with kidney or ureter stones who can take oral medication and are willing to follow the study's procedures. They must have stones no larger than 2cm, need a stent without a string after surgery, and be able to complete surveys. Pregnant women, those allergic to polyurethane or silicone, with certain anatomical anomalies or prior urinary diversions cannot participate.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

I am scheduled for a procedure to examine my ureter with stent placement without a stent string.

My kidney stones are located only in my kidneys or ureters.

Exclusion Criteria

I need a follow-up procedure to remove leftover kidney stone pieces after surgery.

I have had surgery to redirect urine flow.

You have a tube in your ureter before the procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either the Imajin silicone stent or a non-silicone stent after ureteroscopy

7 to 10 days

1 visit (in-person)

Follow-up

Participants complete questionnaires and have follow-up information collected to assess outcomes

60 days

2 visits (in-person), additional virtual follow-ups

Treatment Details

Interventions

• Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)
• Silicone (Coloplast Imajin Hydro) ureteral stent
• Ureteroscopy

Trial Overview This study compares two types of ureteral stents: Imajin silicone stents versus non-silicone polyurethane stents in patients undergoing ureteroscopy for stone removal. Participants will be randomly assigned one type of stent and asked to fill out questionnaires about their experience.

Participant Groups

Group I: Silicone (Coloplast Imajin Hydro) ureteral stent Experimental Treatment 1 Intervention

Group II: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer). Experimental Treatment 1 Intervention

Ureteroscopy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ureteroscopy for:

• Renal calculi
• Ureteral calculi
• Upper urinary tract calculi
• Nephrolithiasis
• Ureteral obstruction

Approved in United States as Ureteroscopy for:

• Kidney stones
• Ureteral stones
• Urinary tract obstruction
• Hematuria
• Ureteral tumors

Approved in Canada as Ureteroscopy for:

• Renal calculi
• Ureteral calculi
• Upper urinary tract calculi
• Nephrolithiasis
• Ureteral obstruction

Approved in Japan as Ureteroscopy for:

• Kidney stones
• Ureteral stones
• Urinary tract obstruction
• Hematuria
• Ureteral tumors

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Coloplast A/S

Industry Sponsor

Trials

155

Recruited

14,800+

Founded

1957

Headquarters

Humlebæk, Denmark

Known For

Intimate Healthcare Solutions

Top Products

Ostomy bags, Continence products, Wound dressings

Kristian Villumsen

Coloplast A/S

Chief Executive Officer since 2018

Master's degree in Political Science from Aarhus University

Preeti Jain

Coloplast A/S

Chief Medical Officer since 2023

MD from University of Copenhagen