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

Sponsor
Albany Medical College (Other)
Overall Status
Recruiting
CT.gov ID
NCT05869890
Collaborator
(none)
120
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3
29.3
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MOSES laser system
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi
Actual Study Start Date :
Feb 22, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: 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

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

Other: 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

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

Other: Flexible Ureteroscopy with Hybrid

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

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

Outcome Measures

Primary Outcome Measures

  1. Reduced OR time [2 hours]

    Hybrid technique will result in overall reduced OR time

  2. Less Energy Transmission to Patient [2 hours]

    Hybrid technique will have less energy transmission to the patient

Secondary Outcome Measures

  1. Stone Free [1 month after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Albany Medical College Albany New York United States 12208

Sponsors and Collaborators

  • Albany Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luay, Assistant Professor of Urology, Albany Medical College
ClinicalTrials.gov Identifier:
NCT05869890
Other Study ID Numbers:
  • 6286
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023