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Laser Modality
MOSES Laser System for Kidney Stones
N/A
Recruiting
Research Sponsored by Albany Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm
Adults between the ages of 18-80
Must not have
Patients with a history of ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi
Patients with a history of prior radiotherapy of the abdomen or pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will test new technique to reduce stone size and time of surgery for patients with large kidney stones.
Who is the study for?
This trial is for adults aged 18-80 with large kidney stones (10-20 mm in total diameter) and a stone density of at least 1000 Hounsfield units. Suitable candidates can undergo flexible ureteroscopy. Pregnant individuals, those currently battling infections or cancer, patients with spinal cord injuries, neurogenic bladder, abnormal kidney anatomy, history of certain urinary tract procedures or strictures, prior abdominal/pelvic radiotherapy, or on non-stop anticoagulants are excluded.
What is being tested?
The study tests the MOSES laser system's effectiveness in reducing lasing time and energy during ureteroscopic removal of large dense kidney stones using different techniques: dusting them into fine particles, breaking them into fragments or combining both methods.
What are the potential side effects?
While not explicitly stated here, typical side effects from similar procedures may include discomfort during urination, blood in urine post-procedure due to tissue irritation by the laser treatment and potential infection risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have large kidney stones measuring in total 10-20 mm.
Select...
I am between 18 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on the same side as my kidney stones before.
Select...
I have had radiation therapy in my abdomen or pelvis before.
Select...
I have an unusual kidney shape, like a horseshoe kidney.
Select...
I am currently receiving treatment for an infection or cancer.
Select...
I have had a spinal cord injury in the past.
Select...
My kidney stones are either smaller than 10mm or larger than 20mm.
Select...
I need to take blood thinners regularly and cannot stop them for surgery.
Select...
I cannot have a tube placed in my ureter.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Less Energy Transmission to Patient
Reduced OR time
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Flexible Ureteroscopy with HybridExperimental Treatment1 Intervention
Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters.
Group II: Flexible Ureteroscopy with FragmentationExperimental Treatment1 Intervention
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 III: Flexible Ureteroscopy with DustingExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
Albany Medical CollegeLead Sponsor
94 Previous Clinical Trials
12,441 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The doctor decides if you can have a flexible ureteroscopy.I have had surgery on the same side as my kidney stones before.You have had problems with your bladder related to nerve issues in the past.I have large kidney stones measuring in total 10-20 mm.You have a history of narrowings in the tube that carries urine from one of your kidneys to your bladder.I have had radiation therapy in my abdomen or pelvis before.Your kidney stone is very dense, with a score of at least 1000 on a special type of X-ray.I have an unusual kidney shape, like a horseshoe kidney.I am currently receiving treatment for an infection or cancer.I have had a spinal cord injury in the past.I am between 18 and 80 years old.Your kidney stone is not dense enough.My kidney stones are either smaller than 10mm or larger than 20mm.I need to take blood thinners regularly and cannot stop them for surgery.I cannot have a tube placed in my ureter.My gender, race, or ethnicity does not affect my eligibility.
Research Study Groups:
This trial has the following groups:- Group 1: Flexible Ureteroscopy with Dusting
- Group 2: Flexible Ureteroscopy with Fragmentation
- Group 3: Flexible Ureteroscopy with Hybrid
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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