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

Albany Medical College

Status: Terminated

Conditions: Renal Calculi

Treatments: Device: MOSES laser system

Study type: Interventional

Funder types: Other

Identifiers

NCT05869890

6286

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 3 patient groups

Flexible Ureteroscopy with Dusting

Other group

Description:

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

Treatment:

Device: MOSES laser system

Flexible Ureteroscopy with Fragmentation

Other group

Description:

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

Treatment:

Device: MOSES laser system

Flexible Ureteroscopy with Hybrid

Other group

Description:

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

Treatment:

Device: MOSES laser system