Renal CalculiNCT05869890
Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi
A study testing MOSES laser system in people with Renal Calculi, run by Albany Medical College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Calculi
- What is being tested?
- MOSES laser system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 27 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Renal Calculi
- Being tested
- MOSES laser system
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOSES laser systemDevice
A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,
| Study group | Role | What they receive |
|---|---|---|
| Flexible Ureteroscopy with Dusting | Other | 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 Receives: Device: MOSES laser system |
| Flexible Ureteroscopy with Fragmentation | Other | Flexible ureteroscopy utilizing the Fragmentation lasing technique. MOSES parameters will be set to 0.8-1 JULES and a frequency of 8-10 hertz Receives: Device: MOSES laser system |
| Flexible Ureteroscopy with Hybrid | Other | Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters. Receives: Device: MOSES laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced OR time
Hybrid technique will result in overall reduced OR time
Measured: 2 hours
Less Energy Transmission to Patient
Hybrid technique will have less energy transmission to the patient
Measured: 2 hours
Secondary outcomes (1)
Stone Free
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start22 Feb 2023
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Why it stopped: Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Romeo, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869890
- Sponsor's protocol ID
- 6286
- Status last verified
- Feb 2025
- First submitted
- 12 May 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi
- ClinicalTrials.gov ID
- NCT05869890
- Acronym / sponsor ID
- 6286
- Conditions
- Renal Calculi
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left the institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexible Ureteroscopy with Dusting | Other | Device: MOSES laser systemFlexible 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 with Fragmentation | Other | Device: MOSES laser systemFlexible 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 with Hybrid | Other | Device: MOSES laser systemFlexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOSES laser systemA holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi, | Device | Flexible Ureteroscopy with Dusting, Flexible Ureteroscopy with Fragmentation, Flexible Ureteroscopy with Hybrid |
Primary outcome
Reduced OR time
Time frame: 2 hours
Hybrid technique will result in overall reduced OR time
Less Energy Transmission to Patient
Time frame: 2 hours
Hybrid technique will have less energy transmission to the patient
1 secondary outcome
Stone Free
Time frame: 1 month after surgery
Results and safety
The study was stopped early (reason given: Investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOSES laser system in people with Renal Calculi, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced OR time (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.