Kidney StoneCoLUMNCT04069338
Comparison of Lithotripsy Urolithiasis Machines
A study testing Lithotripter in people with Kidney Stone and Kidney Calculi, run by The Cleveland Clinic at 1 site in United States.
Trial summary
A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Kidney Calculi, Ureteral Calculi
- What is being tested?
- Lithotripter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 12 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed
- Age ≥ 18 years old
- Male and female patients
- Patients of all ethnic backgrounds
- Stone size 5-15mm
- Stone location: Renal or proximal ureter
Show all 10Show fewer
- Stone density: < 1200 Hounsfield Units
- Skin to stone distance: < 12cm
- Primary treatment for a solitary stone (must be previously untreated)
- Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.
Who cannot join
- Prior treatment for specified stone
- Multiple stones on treatment side (even if only one is treated)
- Anticoagulated or history of coagulopathy
- Prior ureteral stent placement
- Technical problems/impossibility of localizing the stone on the day of intervention
- Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines
A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.
Read the detailed description
This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.
- Conditions
- Kidney Stone, Kidney Calculi, Ureteral Calculi, Ureterolithiasis, Urolithiasis
- Being tested
- Lithotripter
- Keywords
- Lithotripsy, Extracorporeal shockwave lithotripsy
- Medical subject headings
- Kidney Calculi, Ureteral Calculi, Ureterolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithotripterProcedure or surgery
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
| Study group | Role | What they receive |
|---|---|---|
| Device Storz Modulith SLX-F2 | Active comparator | Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2 Receives: Procedure: Lithotripter |
| Dornier Delta III Treatment | Active comparator | Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter Receives: Procedure: Lithotripter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Presence of stone on follow up imaging
Measured: Four weeks post operative
Secondary outcomes (5)
Fluoroscopy time
Length of fluoroscopy exposure
Measured: Intra-operative
Treatment Time
Length of surgical procedure
Measured: Intra-operative
Pain Scores
Response to visual analog scale
Measured: Four days post-operative
Complication Rates
Medical complications
Measured: One month post-operative
Secondary Interventions required
Follow up surgery
Measured: One month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start31 May 2019
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manoj Monga, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069338
- Sponsor's protocol ID
- 19-619
- Acronym
- CoLUM
- Status last verified
- Dec 2023
- First submitted
- 23 Aug 2019
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines
- ClinicalTrials.gov ID
- NCT04069338
- Acronym / sponsor ID
- CoLUM / 19-619
- Conditions
- Kidney Stone, Kidney Calculi, Ureteral Calculi, Ureterolithiasis, Urolithiasis
- Keywords
- Lithotripsy, Extracorporeal shockwave lithotripsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 28 Aug 2019 (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.
A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.
Detailed description
This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Storz Modulith SLX-F2 | Active comparator | Procedure: LithotripterPatients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2 |
| Dornier Delta III Treatment | Active comparator | Procedure: LithotripterPatients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed
- Age ≥ 18 years old
- Male and female patients
- Patients of all ethnic backgrounds
- Stone size 5-15mm
Key exclusion criteria (6 listed)
- Prior treatment for specified stone
- Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
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 |
|---|---|---|
| LithotripterPatients receive standard of care treatment for their urolithiasis using one of two lithotripter machines | Procedure or surgery | Device Storz Modulith SLX-F2, Dornier Delta III Treatment |
Primary outcome
Stone free rate
Time frame: Four weeks post operative
Presence of stone on follow up imaging
5 secondary outcomes
Fluoroscopy time
Time frame: Intra-operative
Treatment Time
Time frame: Intra-operative
Pain Scores
Time frame: Four days post-operative
Complication Rates
Time frame: One month post-operative
Secondary Interventions required
Time frame: One month post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Manoj Monga, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithotripter in people with Kidney Stone and Kidney Calculi, run by The Cleveland Clinic 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 13 Dec 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stone free rate (time frame: Four weeks post operative). 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 13 Dec 2023.