Kidney StoneNCT05022537
Trial of Efficacy of the RetroPerc Device
A study testing retrograde nephrostomy and antegrade nephrostomy in people with Kidney Stone, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of RetroPerc® in obtaining renal access for percutaneous nephrolithotomy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Stone
- What is being tested?
- retrograde nephrostomy and antegrade nephrostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography
Who cannot join
- Suspected pyelonephritis.
- Prior percutaneous nephrolithotomy procedure in affected kidney.
- Mid-ureteral or distal ureteral stones.
- Pregnancy.
- Anatomical abnormal kidney, including:
- Horseshoe
- Ectopic
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: RetroPerc®-A Prospective, Multi-institutional Trial of Efficacy of the RetroPerc Device
The purpose of this study is to determine the efficacy of RetroPerc® in obtaining renal access for percutaneous nephrolithotomy
- Conditions
- Kidney Stone
- Being tested
- retrograde nephrostomy, antegrade nephrostomy
- Keywords
- nephrostomy, Percutaneous nephrolithotomy (PCNL)
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde nephrostomyDevice
this will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months.
antegrade nephrostomyDevice
this will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment (retrograde nephrostomy) | Experimental | Not described Receives: Device: retrograde nephrostomy |
| Control Group ( antegrade nephrostomy) | Active comparator | Not described Receives: Device: antegrade nephrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access
Measured: end of procedure (about 4-8 weeks from diagnosis)
Treatment efficacy as measured by total time of access operation.
Measured: end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of access operation fluoroscopy
Measured: end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation
Measured: end of procedure(about 3 hours after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy
Measured: (end of procedure)about 3 hours after start of procedure
Treatment efficacy as measured by length of post-operative hospital stay
Measured: 24 hours after procedure
Number of patients that are stone free
stone free is defined as <2mm on non-contrast computed tomography
Measured: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of flank pain
Measured: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,
Measured: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to work
Measured: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.
Measured: 6-12 weeks after procedure
Secondary outcomes (5)
Number of patients with nephrostomy access adequate for stone treatment
Measured: end of procedure( abut 3 hours from start of procedure)
Number of patients with normal vital signs
Measured: end of procedure( abut 3 hours from start of procedure)
Number of patients with normal laboratory values
laboratory values include complete metabolic panel and urinalysis
Measured: 24 hours after procedure
Number of patients with an infection rate which is defined as a positive culture within the study time period
Measured: 6-12 weeks after procedure
Number of patients that require pain medication (defined as discharge with an opioid prescription).
Measured: 6-12 weeks after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Jul 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: contract never completed
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 University of Texas Health Science Center, HoustonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadeem N Dhanani, The University of Texas Health Science Center, Houston
- Investigators
- Nadeem N Dhanani, MD,MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022537
- Sponsor's protocol ID
- HSC-MS-20-1269
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RetroPerc®-A Prospective, Multi-institutional Trial of Efficacy of the RetroPerc Device
- ClinicalTrials.gov ID
- NCT05022537
- Acronym / sponsor ID
- HSC-MS-20-1269
- Conditions
- Kidney Stone
- Keywords
- nephrostomy, Percutaneous nephrolithotomy (PCNL)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: contract never completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Aug 2021 (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.
The purpose of this study is to determine the efficacy of RetroPerc® in obtaining renal access for percutaneous nephrolithotomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (retrograde nephrostomy) | Experimental | Device: retrograde nephrostomy |
| Control Group ( antegrade nephrostomy) | Active comparator | Device: antegrade nephrostomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography
Key exclusion criteria (7 listed)
- Suspected pyelonephritis.
- Prior percutaneous nephrolithotomy procedure in affected kidney.
- Mid-ureteral or distal ureteral stones.
- Pregnancy.
- Anatomical abnormal kidney, including:
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 |
|---|---|---|
| retrograde nephrostomythis will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months. | Device | Treatment (retrograde nephrostomy) |
| antegrade nephrostomythis will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months | Device | Control Group ( antegrade nephrostomy) |
Primary outcome
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access
Time frame: end of procedure (about 4-8 weeks from diagnosis)
Treatment efficacy as measured by total time of access operation.
Time frame: end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of access operation fluoroscopy
Time frame: end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation
Time frame: end of procedure(about 3 hours after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy
Time frame: (end of procedure)about 3 hours after start of procedure
Treatment efficacy as measured by length of post-operative hospital stay
Time frame: 24 hours after procedure
Number of patients that are stone free
Time frame: 6-12 weeks after procedure
stone free is defined as <2mm on non-contrast computed tomography
Number of patients with symptom free survival as defined as lack of flank pain
Time frame: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,
Time frame: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to work
Time frame: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.
Time frame: 6-12 weeks after procedure
5 secondary outcomes
Number of patients with nephrostomy access adequate for stone treatment
Time frame: end of procedure( abut 3 hours from start of procedure)
Number of patients with normal vital signs
Time frame: end of procedure( abut 3 hours from start of procedure)
Number of patients with normal laboratory values
Time frame: 24 hours after procedure
Number of patients with an infection rate which is defined as a positive culture within the study time period
Time frame: 6-12 weeks after procedure
Number of patients that require pain medication (defined as discharge with an opioid prescription).
Time frame: 6-12 weeks after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- 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.
Nadeem N Dhanani, MD,MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retrograde nephrostomy and antegrade nephrostomy in people with Kidney Stone, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 9 Mar 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 was withdrawn before enrolling participants, so there are no results.
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?
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access (time frame: end of procedure (about 4-8 weeks from diagnosis)). The study lists 11 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 9 Mar 2026.