What is the mechanism of action of this treatment?

The most common treatments for kidney stones, such as the Ambulatory Tubeless Miniperc and retrograde intrarenal surgery (RIRS), work by physically removing the stones from the kidney. The Ambulatory Tubeless Miniperc involves percutaneous removal without a nephrostomy tube, which helps to reduce postoperative pain, morbidity, and hospital stay. These minimally invasive techniques are designed to break down and extract stones, providing relief from symptoms and preventing further complications. This approach is significant for patients as it aims to enhance recovery and improve overall quality of life by minimizing the invasiveness and associated risks of the procedure.

What side effects are associated with this type of intervention?

Common treatments for kidney stones, such as mini-percutaneous nephrolithotomy (mini-PCNL) and flexible ureteroscopy (fURS), can have side effects including bleeding, infection, injury to the kidney or surrounding organs, and postoperative pain. There is also a risk of urinary leakage and the potential need for additional procedures if stones are not fully removed. The Ambulatory Tubeless Miniperc aims to reduce morbidity and hospital stay by avoiding the use of a nephrostomy tube, which may help mitigate some of these side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for kidney stones, including surgical techniques such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). These methods are effective for removing kidney stones, particularly those located in the lower pole of the kidney. The Ambulatory Tubeless Miniperc procedure, which is being studied for its potential to reduce morbidity and hospital stay by avoiding the use of a nephrostomy tube, is a variation of the standard PCNL technique. While specific FDA approvals for this exact procedure are not detailed, the broader category of PCNL and related minimally invasive surgeries are well-established and approved for the treatment of nephrolithiasis.

What other types of research exist?

Promising novel alternatives to Ambulatory Tubeless Miniperc for kidney stone treatment include Retrograde Intrarenal Surgery (RIRS) and Urolift. Both methods are minimally invasive and have demonstrated safety and effectiveness in treating lower pole nephrolithiasis. These alternatives may offer reduced morbidity and shorter hospital stays, making them viable options for patients in 2024.

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Procedure

Mini-PNCL vs fURS for Kidney Stones

N/A

Waitlist Available

Led By Hazem Elmansy, MD

Research Sponsored by Thunder Bay Regional Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx

Be older than 18 years old

Must not have

Participants who lack the capacity to provide free and informed written consent

Patients with solitary kidney

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods for removing lower pole kidney stones in patients with stones that are 1-2 cm in size. One method uses a small surgical cut without leaving a tube, while the other uses a flexible tool inserted through the urinary tract. The goal is to see which method is more effective and has fewer complications.

Who is the study for?

This trial is for adults over 18 with single kidney stones sized 10-20 mm or multiple stones in one calyx. They must be able to follow the study's procedures and give written consent. It excludes those with larger/multiple stones, previous treatments, urinary infections, bleeding disorders, pregnancy, extreme obesity, or certain preexisting conditions.

What is being tested?

The trial compares two techniques for treating lower pole kidney stones: mini-percutaneous nephrolithotomy (Mini-PNCL) and flexible ureteroscopy (fURS). The goal is to see which method is safer and more effective when performed as a same-day procedure without hospital admission.

What are the potential side effects?

Possible side effects include pain at the surgical site, bleeding, infection risk from surgery, potential damage to surrounding tissues or organs during the procedure. There may also be complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a kidney stone or stones in one area, measuring 10-20 mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and sign the consent form by myself.

Select...

I have only one kidney.

Select...

I have had shock wave therapy for the same kidney stone before.

Select...

I have a kidney stone larger than 20 mL or multiple stones in different parts of my kidney.

Select...

I cannot stop my blood thinners before surgery.

Select...

I have a stone or narrowing in the tube on the same side as my bladder.

Select...

I had kidney surgery on the same side within the last 5 years.

Select...

I was born with abnormalities in my kidney, ureters, or bladder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stone-free status

Secondary study objectives

Pain

To compare safety measures

To compare stone free status of single use vs reusable fURS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Flexible ureteroscopy (fURS)Active Control1 Intervention

Retrograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.

Group II: Mini-percutaneous nephrolithotomy (mini-PCNL)Active Control1 Intervention

PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs)4

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for kidney stones, such as the Ambulatory Tubeless Miniperc and retrograde intrarenal surgery (RIRS), work by physically removing the stones from the kidney. The Ambulatory Tubeless Miniperc involves percutaneous removal without a nephrostomy tube, which helps to reduce postoperative pain, morbidity, and hospital stay. These minimally invasive techniques are designed to break down and extract stones, providing relief from symptoms and preventing further complications. This approach is significant for patients as it aims to enhance recovery and improve overall quality of life by minimizing the invasiveness and associated risks of the procedure.