Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2025-04-30

Brief Summary

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The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.

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Detailed Description

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Conditions

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Kidney Stone Renal Stone Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SURE

Group Type ACTIVE_COMPARATOR

SURE

Intervention Type DEVICE

The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.

Standard Ureteroscopy (Basketing)

Group Type ACTIVE_COMPARATOR

Standard Ureteroscopy (Basketing)

Intervention Type DEVICE

This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.

Interventions

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SURE

The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.

Intervention Type DEVICE

Standard Ureteroscopy (Basketing)

This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Candidate for ureteroscopy with laser lithotripsy;
* Presence of renal stone(s);
* Be willing and able to return for all study-related follow up procedures; and,
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.

Exclusion Criteria

* BMI \> 45;
* Significant comorbidities;
* Bladder, ureteral or kidney abnormalities;
* Pregnant individuals; or
* Unable to meet the treatment and follow up protocol requirements.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No