NephrolithiasisNCT05872230
Massage Percussion for Passage of Urolithiasis Fragments After Ureteroscopy.
A study testing Massage Percussion Therapy device in people with Nephrolithiasis, run by Vanderbilt University Medical Center at 1 site in Canada.
Trial summary
Flexible ureteroscopy is characterized as first-line therapy for renal stones < 2 cm in size. Stones are commonly treated with dusting or fragmentation techniques which requires passage of stone fragments after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Massage Percussion Therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2024to 15 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient after treatment of renal stones with ureteroscopy during which residual stone fragments (less than 2mm by surgeon estimation) is left in the kidney.
- Must be 18 years or older
- Must be able to give consent
- Preoperative abdominal CT
Who cannot join
- On pharmacologic anticoagulation. Aspirin up to 81mg will be allowed.
- Cannot tolerate flank, prone or Trendelenburg position.
- Cannot tolerate percussion.
- History of acute rib fractures or osteopenia/osteoporosis.
- Any patient who is on a fluid intake restriction.
- Pregnancy
Show all 11Show fewer
- Untreated UTI
- History of struvite stones
- Requiring a planned secondary stone procedure within 90 days
- If stent must stay in longer than 10 days
- Ureteral stones (without renal stones)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Massage Percussion Therapy for Passage of Urolithiasis Fragments After Ureteroscopy
Flexible ureteroscopy is characterized as first-line therapy for renal stones < 2 cm in size. Stones are commonly treated with dusting or fragmentation techniques which requires passage of stone fragments after surgery. Quoted stone free rate after flexible ureteroscopy is approximately 40-60% with a dusting technique. Residual fragments are often under 1mm in size and can layer in the lower pole of the kidney, complicating spontaneous stone passage. Improving the stone free rate after surgery decreases the need for secondary surgeries and decreases risk of future stone events.
Numerous techniques have been proposed to increase stone passage including positional changes and percussion therapy. To date, there is overall limited data a lack of techniques that can be readily available in the outpatient setting, easily added to scheduled appointments, reproducible results and well tolerated by patients.
Read the detailed description
Researchers in China have developed a proprietary oscillation machine to be used in an outpatient setting. The External Physical Vibration Lithecbole (EPVL) is used to provide vibration after stone fragmentation to facilitate movement of fragments into a more favorable orientation for stone passage. After extracorporeal shockwave lithotripsy and ureteroscopy, use of EPVL after surgery has been shown to increase stone free rate.
Chest percussion for cystic fibrosis patients has been adapted for use after ureteroscopy. After undergoing extracorporeal shockwave lithotripsy, patients are placed in a percussion physiotherapy vest, given diuretics and positioned in Trendelenburg. Imaging obtained before and after percussion demonstrates successful stone movement and increases stone free rates in several different protocols compared to patients who do not receive percussive therapy.
Percussion therapy is clearly effective to improve stone free rates after ureteroscopy and is effective regardless of technique, protocol, or percussive device. However, proposed techniques with EPVL and chest physiotherapy vests can be expensive, cumbersome and require specialty equipment. In addition, proposed equipment in prior studies is not readily available in outpatient clinics.
- Conditions
- Nephrolithiasis
- Being tested
- Massage Percussion Therapy device
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage Percussion Therapy deviceDevice
Using massage percussion postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patient receives standard postoperative care with no percussion therapy. |
| PACU percussion | Experimental | Patient receives percussion therapy in the PACU immediately after surgery. Receives: Device: Massage Percussion Therapy device |
| Postoperative appointment percussion | Experimental | Patient receives percussion therapy in the office on the day of follow up. Receives: Device: Massage Percussion Therapy device |
| Both PACU and Postop appointment percussion. | Experimental | Patient receives percussion therapy in the PACU and receives percussion therapy in the office on the day of follow up. Receives: Device: Massage Percussion Therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who are able to tolerate and complete the percussion therapy.
If patients can tolerate the percussion therapy in the treatment arms. This is evaluated by patients being able to complete the percussion therapy session and completing pain questionnaires.
Measured: Postop day 0-10.
Stone Free Rate.
Patients will have standard postoperative imaging at six weeks, as is standard of care. Presence of stone fragments and fragment size will determine the postoperative stone free rate.
Measured: 6 weeks after surgery.
Secondary outcomes (2)
weight of passed stone fragments
PAtients will strain urine to collect stone fragments after surgery until stent removal. The stone fragments will be sent for stone analysis, as is standard of care, during which fragments will be weighed.
Measured: 6 weeks.
Unplanned return visits.
Follow patients who have unplanned return trips to the ED or the clinic for pain or complications after surgery.
Measured: 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Feb 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Why it stopped: Investigators terminated study given recent advancements in ureteroscopic technique and suction technique.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Hsi, Vanderbilt University Medical Center
- Investigators
- Ryan Hsi, Principal investigator, VUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872230
- Sponsor's protocol ID
- VUMC01
- Status last verified
- Jul 2026
- First submitted
- 4 May 2023
- Last updated
- 7 Jul 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage Percussion Therapy for Passage of Urolithiasis Fragments After Ureteroscopy
- ClinicalTrials.gov ID
- NCT05872230
- Acronym / sponsor ID
- VUMC01
- Conditions
- Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators terminated study given recent advancements in ureteroscopic technique and suction technique.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 24 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.
Flexible ureteroscopy is characterized as first-line therapy for renal stones < 2 cm in size. Stones are commonly treated with dusting or fragmentation techniques which requires passage of stone fragments after surgery. Quoted stone free rate after flexible ureteroscopy is approximately 40-60% with a dusting technique. Residual fragments are often under 1mm in size and can layer in the lower pole of the kidney, complicating spontaneous stone passage. Improving the stone free rate after surgery decreases the need for secondary surgeries and decreases risk of future stone events.
Numerous techniques have been proposed to increase stone passage including positional changes and percussion therapy. To date, there is overall limited data a lack of techniques that can be readily available in the outpatient setting, easily added to scheduled appointments, reproducible results and well tolerated by patients.
Detailed description
Researchers in China have developed a proprietary oscillation machine to be used in an outpatient setting. The External Physical Vibration Lithecbole (EPVL) is used to provide vibration after stone fragmentation to facilitate movement of fragments into a more favorable orientation for stone passage. After extracorporeal shockwave lithotripsy and ureteroscopy, use of EPVL after surgery has been shown to increase stone free rate.
Chest percussion for cystic fibrosis patients has been adapted for use after ureteroscopy. After undergoing extracorporeal shockwave lithotripsy, patients are placed in a percussion physiotherapy vest, given diuretics and positioned in Trendelenburg. Imaging obtained before and after percussion demonstrates successful stone movement and increases stone free rates in several different protocols compared to patients who do not receive percussive therapy.
Percussion therapy is clearly effective to improve stone free rates after ureteroscopy and is effective regardless of technique, protocol, or percussive device. However, proposed techniques with EPVL and chest physiotherapy vests can be expensive, cumbersome and require specialty equipment. In addition, proposed equipment in prior studies is not readily available in outpatient clinics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patient receives standard postoperative care with no percussion therapy. |
| PACU percussion | Experimental | Device: Massage Percussion Therapy devicePatient receives percussion therapy in the PACU immediately after surgery. |
| Postoperative appointment percussion | Experimental | Device: Massage Percussion Therapy devicePatient receives percussion therapy in the office on the day of follow up. |
| Both PACU and Postop appointment percussion. | Experimental | Device: Massage Percussion Therapy devicePatient receives percussion therapy in the PACU and receives percussion therapy in the office on the day of follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient after treatment of renal stones with ureteroscopy during which residual stone fragments (less than 2mm by surgeon estimation) is left in the kidney.
- Must be 18 years or older
- Must be able to give consent
- Preoperative abdominal CT
Key exclusion criteria (11 listed)
- On pharmacologic anticoagulation. Aspirin up to 81mg will be allowed.
- Cannot tolerate flank, prone or Trendelenburg position.
- Cannot tolerate percussion.
- History of acute rib fractures or osteopenia/osteoporosis.
- Any patient who is on a fluid intake restriction.
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 |
|---|---|---|
| Massage Percussion Therapy deviceUsing massage percussion postoperatively. | Device | Both PACU and Postop appointment percussion., PACU percussion, Postoperative appointment percussion |
Primary outcome
Patients who are able to tolerate and complete the percussion therapy.
Time frame: Postop day 0-10.
If patients can tolerate the percussion therapy in the treatment arms. This is evaluated by patients being able to complete the percussion therapy session and completing pain questionnaires.
Stone Free Rate.
Time frame: 6 weeks after surgery.
Patients will have standard postoperative imaging at six weeks, as is standard of care. Presence of stone fragments and fragment size will determine the postoperative stone free rate.
2 secondary outcomes
weight of passed stone fragments
Time frame: 6 weeks.
Unplanned return visits.
Time frame: 6 weeks.
Results and safety
The study was stopped early (reason given: Investigators terminated study given recent advancements in ureteroscopic technique and suction technique.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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.
Ryan Hsi principal investigator
VUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Percussion Therapy device in people with Nephrolithiasis, run by Vanderbilt University Medical Center at 1 site in Canada.
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 4 inclusion and 11 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 7 Jul 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 Canada. 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: Investigators terminated study given recent advancements in ureteroscopic technique and suction technique.). 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?
Patients who are able to tolerate and complete the percussion therapy. (time frame: Postop day 0-10.). 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 7 Jul 2026.