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

Primary Purpose

Renal Calculi

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOSES laser system
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Calculi

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Albany Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Flexible Ureteroscopy with Dusting

Flexible Ureteroscopy with Fragmentation

Flexible Ureteroscopy with Hybrid

Arm 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

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

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

Outcomes

Primary Outcome Measures

Reduced OR time
Hybrid technique will result in overall reduced OR time
Less Energy Transmission to Patient
Hybrid technique will have less energy transmission to the patient

Secondary Outcome Measures

Stone Free

Full Information

First Posted
May 12, 2023
Last Updated
May 12, 2023
Sponsor
Albany Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05869890
Brief Title
Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi
Official Title
Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flexible Ureteroscopy with Dusting
Arm Type
Other
Arm 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
Arm Title
Flexible Ureteroscopy with Fragmentation
Arm Type
Other
Arm 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
Arm Title
Flexible Ureteroscopy with Hybrid
Arm Type
Other
Arm Description
Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters.
Intervention Type
Device
Intervention Name(s)
MOSES laser system
Intervention Description
A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,
Primary Outcome Measure Information:
Title
Reduced OR time
Description
Hybrid technique will result in overall reduced OR time
Time Frame
2 hours
Title
Less Energy Transmission to Patient
Description
Hybrid technique will have less energy transmission to the patient
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Stone Free
Time Frame
1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Davey
Phone
518-262-8579
Email
AMCUrologyresearch@amc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Romeo
Phone
518-262-3349
Email
AMCUrologyresearch@amc.edu
Facility Information:
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Davey
Phone
518-262-8579
Email
AMCUrologyresearch@amc.edu
First Name & Middle Initial & Last Name & Degree
Brenda Romeo
Phone
518-262-3349
Email
AMCUrologyresearch@amc.edu
First Name & Middle Initial & Last Name & Degree
Luay Alshara, MD
First Name & Middle Initial & Last Name & Degree
Mark White, MD

12. IPD Sharing Statement

Learn more about this trial

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

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