UrolithiasisNCT04069013
Standard vs Mini-PCNL for the Treatment of Stone Disease
A study testing PCNL in people with Urolithiasis and Kidney Stone, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Kidney Stone, Kidney Calculi
- What is being tested?
- PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 11 Nov 2025
- 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
- Patients planned for PCNL at participating institutions
- Age ≥ 18 years old
- Male and female patients
- Patients of all ethnic backgrounds
- Stone size 10-20mm
- 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
- Conversion to open procedure
- Multiple access tracts
- Anticoagulated or history of coagulopathy
- Preoperative ureteral stent or nephrostomy tube 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 Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.
Read the detailed description
This study is a randomized controlled trial which compares the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. This study will be a multi-institutional, prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either standard PCNL or mini-PCNL, defined as tract sizes of 30 and 16.5 to 18 French respectively. Patients will be asked to complete pre-operative, and post-operative quality of life questionnaires, and to allow collection of one additional vial of blood for measurement of factors associated with inflammation. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE research consortium.
- Conditions
- Urolithiasis, Kidney Stone, Kidney Calculi, Ureteral Calculi, Kidney Diseases
- Being tested
- PCNL
- Keywords
- Percutaneous Nephrolithotomy, PCNL
- Medical subject headings
- Urolithiasis, Kidney Calculi, Ureteral Calculi, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNLProcedure or surgery
Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL
| Study group | Role | What they receive |
|---|---|---|
| Standard PCNL | Active comparator | Patients receive a standard PCNL procedure using a 24 fr tract Receives: Procedure: PCNL |
| Mini-PCNL | Active comparator | Patients receive a mini-PCNL procedure using a 16 fr tract Receives: Procedure: PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Post-op decreases in hemoglobin
Measured: Post-operative day 1
Secondary outcomes (5)
Surgical outcomes
Discharge time
Measured: 30 Days
Complication Rates
Complication Rates
Measured: 30 Days
Renal Pelvis Pressures
Intraoperative renal pelvis pressures
Measured: Intraoperative
Procalcitonin- Inflammatory Markers
Procalcitonin
Measured: Post operative day 1
IL-6 Inflammatory Markers
IL-6
Measured: Post operative day 1
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 start1 May 2022
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Massachusetts General Hospital, Vanderbilt University Medical Center, Duke University, Ohio State University, Columbia University, Dartmouth-Hitchcock Medical Center
- Responsible party
- Sponsor
- Investigators
- Manoj Monga, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069013
- Sponsor's protocol ID
- 19-589
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2019
- Last updated
- 7 Jan 2026
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
- ClinicalTrials.gov ID
- NCT04069013
- Acronym / sponsor ID
- 19-589
- Conditions
- Urolithiasis, Kidney Stone, Kidney Calculi, Ureteral Calculi, Kidney Diseases
- Keywords
- Percutaneous Nephrolithotomy, PCNL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- University of British Columbia, Massachusetts General Hospital, Vanderbilt University Medical Center, Duke University, Ohio State University, Columbia University, Dartmouth-Hitchcock Medical Center
- Study start
- 1 May 2022 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (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.
Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.
Detailed description
This study is a randomized controlled trial which compares the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. This study will be a multi-institutional, prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either standard PCNL or mini-PCNL, defined as tract sizes of 30 and 16.5 to 18 French respectively. Patients will be asked to complete pre-operative, and post-operative quality of life questionnaires, and to allow collection of one additional vial of blood for measurement of factors associated with inflammation. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE research consortium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard PCNL | Active comparator | Procedure: PCNLPatients receive a standard PCNL procedure using a 24 fr tract |
| Mini-PCNL | Active comparator | Procedure: PCNLPatients receive a mini-PCNL procedure using a 16 fr tract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients planned for PCNL at participating institutions
- Age ≥ 18 years old
- Male and female patients
- Patients of all ethnic backgrounds
- Stone size 10-20mm
Key exclusion criteria (6 listed)
- Conversion to open procedure
- Multiple access tracts
- Anticoagulated or history of coagulopathy
- Preoperative ureteral stent or nephrostomy tube placement
- Technical problems/impossibility of localizing the stone on the day of intervention
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 |
|---|---|---|
| PCNLPatients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL | Procedure or surgery | Mini-PCNL, Standard PCNL |
Primary outcome
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss
Time frame: Post-operative day 1
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Post-op decreases in hemoglobin
5 secondary outcomes
Surgical outcomes
Time frame: 30 Days
Complication Rates
Time frame: 30 Days
Renal Pelvis Pressures
Time frame: Intraoperative
Procalcitonin- Inflammatory Markers
Time frame: Post operative day 1
IL-6 Inflammatory Markers
Time frame: Post operative day 1
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 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Urolithiasis
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Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
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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 PCNL in people with Urolithiasis and Kidney Stone, 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 6 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 7 Jan 2026. 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?
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss (time frame: Post-operative day 1). 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 7 Jan 2026.