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Percussion Therapy for Kidney Stones

N/A
Recruiting
Led By Ryan Hsi
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be 18 years or older
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 not have
Any patient who is on a fluid intake restriction.
History of struvite stones
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postop day 0-10.
Awards & highlights
No Placebo-Only Group

Summary

This trial explored a novel technique of positional changes and percussion therapy to improve stone passage after flexible ureteroscopy. A novel technique was tested to improve stone passage after flexible ureteroscopy to reduce the need for additional surgeries and decrease risk of future stone events.

Who is the study for?
This trial is for adults who can consent and have had ureteroscopy to treat kidney stones, leaving behind tiny fragments. They must be able to undergo percussion therapy and not have conditions like osteoporosis, fluid intake restrictions, untreated UTIs, or need for secondary stone procedures soon.
What is being tested?
The study tests a Massage Percussion Therapy device on patients after ureteroscopy to see if it helps pass small kidney stone fragments left in the kidney. The goal is to reduce the need for additional surgeries by increasing the rate of spontaneous stone passage.
What are the potential side effects?
Potential side effects may include discomfort from percussion therapy, especially in sensitive areas like where surgery was performed. Patients with certain bone conditions cannot participate due to risk of injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I had kidney stone removal with some tiny stones left.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on a doctor-recommended fluid intake restriction.
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I have had struvite kidney stones in the past.
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I cannot lie on my side, stomach, or with my head lower than my feet.
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I have a urinary tract infection that hasn't been treated.
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I have had broken ribs or have been diagnosed with weak bones.
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I have stones in my ureter but not in my kidneys.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postop day 0-10.
This trial's timeline: 3 weeks for screening, Varies for treatment, and postop day 0-10. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patients who are able to tolerate and complete the percussion therapy.
Stone Free Rate.
Secondary study objectives
Unplanned return visits.
weight of passed stone fragments

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Postoperative appointment percussionExperimental Treatment1 Intervention
Patient receives percussion therapy in the office on the day of follow up.
Group II: PACU percussionExperimental Treatment1 Intervention
Patient receives percussion therapy in the PACU immediately after surgery.
Group III: Both PACU and Postop appointment percussion.Experimental Treatment1 Intervention
Patient receives percussion therapy in the PACU and receives percussion therapy in the office on the day of follow up.
Group IV: ControlActive Control1 Intervention
Patient receives standard postoperative care with no percussion therapy.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
901 Previous Clinical Trials
938,602 Total Patients Enrolled
Ryan HsiPrincipal InvestigatorVUMC

Media Library

PACU percussion Clinical Trial Eligibility Overview. Trial Name: NCT05872230 — N/A
Kidney stones Research Study Groups: PACU percussion, Both PACU and Postop appointment percussion., Control, Postoperative appointment percussion
Kidney stones Clinical Trial 2023: PACU percussion Highlights & Side Effects. Trial Name: NCT05872230 — N/A
PACU percussion 2023 Treatment Timeline for Medical Study. Trial Name: NCT05872230 — N/A
~0 spots leftby Dec 2024
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