Mini PCNL vs Flex URS for Kidney Stones

Overseen By Allaa Fadl-Alla, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Pregnancy, Anomalous renal anatomy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two common procedures—mini-PCNL and ureteroscopy—for removing kidney stones. Researchers seek to determine which method more effectively clears stones using the ClearPETRA suction access sheath. The trial seeks participants with kidney stones between 1 to 3 cm, as shown on a CT scan, who can complete a questionnaire. Participants will undergo one of the two procedures to assess which one leaves them stone-free. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance kidney stone treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ClearPETRA suction access sheath is safe for kidney stone treatment?

Research has shown that both treatments in this study, mini-PCNL and ureteroscopy, safely remove kidney stones.

For mini-PCNL, studies indicate that continuous suction during the procedure reduces infections and shortens surgery time. This method effectively removes kidney stones while minimizing risks.

Ureteroscopy with the ClearPETRA sheath also shows promising safety results. This flexible sheath increases the procedure's success rate while maintaining low pressure inside the kidney, reducing complications.

Both treatment methods have been tested and used regularly, demonstrating a good safety record for patients with kidney stones. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two advanced methods for removing kidney stones: Mini-PCNL and Ureteroscopy, both using the ClearPETRA suction access sheath. This sheath is unique because it allows for suction during stone removal, potentially reducing procedure time and increasing stone clearance rates. The Mini-PCNL approach allows for a larger access size, making it potentially more effective for larger stones, while the Ureteroscopy utilizes the MOSES 2.0 high power Holmium laser, which offers precise targeting of stones with minimal tissue damage. By comparing these techniques, researchers hope to identify which method provides better outcomes for patients with kidney stones.

What evidence suggests that this trial's treatments could be effective for kidney stones?

This trial will compare the effectiveness of mini-PCNL and ureteroscopy for kidney stones, both using the ClearPETRA suction access sheath. Studies have shown promising results for both procedures. Participants in the mini-PCNL arm may achieve a high success rate for removing kidney stones, ranging from 81% to 96.7%, demonstrating its effectiveness in clearing stones. It also results in fewer infections and shorter surgery times. Meanwhile, participants in the ureteroscopy arm may benefit from the ClearPETRA sheath, which enhances stone removal and reduces the risk of post-procedure fever. It also shortens surgery time, particularly for larger stones. Both procedures show strong potential for effectively treating kidney stones with the ClearPETRA sheath. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with kidney stones, including struvite and nephrolithiasis. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the procedures being compared.

Inclusion Criteria

Have a CT scan showing renal stones 1-3cm in length

Patients who will be able to read, understand, and complete patient questionnaires

I am 18 years old or older.

Exclusion Criteria

I have a urinary diversion in place.

Pregnant individuals

Non-English speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Mini-PCNL or Ureteroscopy with ClearPETRA access sheaths to treat renal calculi

1 day

1 visit (in-person)

Follow-up

Participants are monitored for stone free rate and complications post-procedure

4 weeks

1 visit (in-person), additional follow-up as needed

Extended Follow-up

Participants are monitored for unplanned hospital visits and need for additional procedures

90 days

What Are the Treatments Tested in This Trial?

Interventions

• ClearPETRA suction access sheath

Trial Overview The study compares two standard treatments for kidney stones: ureteroscopy using a ClearPETRA suction access sheath versus mini-PCNL (a type of minimally invasive surgery). The goal is to see which method more effectively removes all kidney stones.

How Is the Trial Designed?

Group I: Mini-PCNL Active Control 1 Intervention

Will be performed by first starting with supine flexible cystoscopy to cannulate the ureteral orifice with a 5Fr open ended ureteral catheter. The patient will then be repositioned prone with 1-2 bumps placed transversely across the chest. Contrast will be instilled into the ureteral catheter and renal access will be obtained fluoroscopically with the triangulation technique. Once access is obtained, the tract will be dilated to 20Fr and a 18/20Fr ClearPETRA renal access sheath will be inserted to assess the collecting system. If there is concern that the 20Fr access is not sufficient to clear the stone, the tract will be upsized to 24 or 30Fr. The stones will be evacuated with the Trilogy Lithotripter and/or laser, suction and/or basket extraction. A ureteral stent will be placed at the conclusion of the procedure.

Group II: Ureteroscopy Active Control 1 Intervention

Patients randomized to this arm will have their stones treated using the method of Ureteroscopy in a standardized fashion. A second 0.035in sensor guidewire will then be advanced up to the renal pelvis with placement confirmed by fluoroscopy. Placement of a 12/14Fr ClearPETRA ureteral access sheath will be attempted. If this is unsuccessful, a 11/13Fr ClearPETRA ureteral access sheath will be advanced over the wire. If this is unsuccessful, a 5Fr open ended ureteral catheter will be placed and procedure will be converted to a miniPCNL. Lithotripsy will be performed with the MOSES 2.0 high power Holmium laser with settings of 0.3J and 120Hz or 2J and 20Hz depending on stone location and appearance. Stones will be extracted with the suction access sheath. A ureteral stent will be placed at the conclusion of the procedure.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

KARL STORZ Endoscopy-America, Inc.

Industry Sponsor

Trials

13

Recruited

21,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11084567/

Assessment of Effectiveness and Safety of Aspiration-Assisted ... Overall, the reported stone free rates for suctioning miniPCNL with the patented sheath ranged from 81% to 96.7%, and complication rates varied from 8.3% to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07072598

Comparing Efficiency and Stone-Free Rates Mini PCNL vs ... The ClearPETRA ureteral access sheath has shown great promise with improving stone free rates, decreasing intra-renal pressure and delivering some of the ...

3. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003397

Data From a Prospective, Randomized Clinical Trial We evaluate the outcomes of ureteroscopy vs prone mini-percutaneous nephrolithotomy for 1-2–cm renal stones using a 2-group parallel randomized control trial.

4. liebertpub.com liebertpub.com/doi/full/10.1089/end.2020.0555

Clinical Comparison of Mini-Percutaneous ... Conclusions: Mini-PCNL performed with continuous active suction is associated with lower rates of infectious complications, shorter OT, and lower patient ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2214388218300328

Miniaturised percutaneous nephrolithotomy: Its role in the ... Our results from propensity score-matched analysis showed that SMP was equally effective as MPCNL for large renal stones (>2 cm), and was comparatively more ...

6. auajournals.org auajournals.org/doi/pdf/10.1097/JU.0000000000004057

Miniaturized Percutaneous Nephrolithotomy With Vacuum- ... The vacuum-assisted access sheath removes stones through an oblique side channel that is connected to negative pressure suction via a stone- ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2173578623000653

Vacuum-assisted access sheath in supine mini- ... Patients treated with Va-PCNL had comparable results to Mini-PCNL, showing equal SFR with similar infectious complications rates. Potential benefits of Va-PCNL ...