Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients.
NCT03602807 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2018-07-27
Summary
The aim is to investigate the safety and potential effect of Low-energy Shockwave Therapy (ESWT) on the transplanted kidney. The treatment consist of ESWT two times a week for three weeks, six treatments in total.
The hypothesis is that ESWT with improve the renal function, by reducing proteinuria (in a 24-hour urine collection test) and improving renal clearance of 51Cr-EDTA.
The safety of ESWT on the renal allograft will be assessed during and after treatments.
Conditions
- Transplant Dysfunction
Interventions
- DEVICE
-
Extracorporeal Shockwave Therapy
2 treatments a week for 3 weeks consisting of 3000 focused shockwaves of 4Hz and 0,20mJ/mm2 applied over the kidney allograft. Treatment is performed using the STORZ DUOLITH® SD1 T-TOP "F-SW ultra"
Sponsors & Collaborators
-
Odense University Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-26
- Primary Completion
- 2020-01-31
- Completion
- 2020-01-31
Countries
- Denmark
Study Locations
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