Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi

NCT ID: NCT05869890

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2024-08-27

Brief Summary

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This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.

Detailed Description

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This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more. Additionally, we will observe the impact of these parameters on total operative time.

Conditions

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Renal Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Flexible Ureteroscopy with Dusting

Flexible ureteroscopy with the dusting lasing technique. MOSES parameters will be set to an energy of 0.3-0.4 Jules and a frequency of 50-80 hertz

Group Type OTHER

MOSES laser system

Intervention Type DEVICE

A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,

Flexible Ureteroscopy with Fragmentation

Flexible ureteroscopy utilizing the Fragmentation lasing technique. MOSES parameters will be set to 0.8-1 JULES and a frequency of 8-10 hertz

Group Type OTHER

MOSES laser system

Intervention Type DEVICE

A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,

Flexible Ureteroscopy with Hybrid

Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters.

Group Type OTHER

MOSES laser system

Intervention Type DEVICE

A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,

Interventions

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MOSES laser system

A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults between the ages of 18-80.
* Any gender, race or ethnicity may be included- these factors play a small, if any role on renal calculi formation and ability to withstand procedure.
* Must be suitable for a flexible ureteroscopy as determined by the MD
* Large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm
* An average stone density of at least 1000 Hounsfield units.

Exclusion Criteria

* Those with a stone burden less than 10mm or more than 20mm.
* Those with an average stone density below 1000 Hounsfield units.
* Patients who are dependent on mandatory anticoagulation therapies and cannot stop for surgery
* Patients that cannot undergo ureteral access sheath placement
* Patients with abnormal anatomy such as horseshoe kidney
* Patients with a history of:

* Ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi
* Ipsilateral ureteral strictures
* Prior radiotherapy of the abdomen or pelvis
* Neurogenic bladder
* Spinal cord injuries
* Those who are pregnant
* Currently being treated for infection or cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albany Medical College

OTHER

Sponsor Role lead

Responsible Party

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Brenda Romeo

Research Manager for Luay Alshara

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Albany Medical College

Albany, New York, United States

Site Status

Countries

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United States

Other Identifiers

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6286

Identifier Type: -

Identifier Source: org_study_id

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