MedDRA - 10038344
Conditions
Interventions
Group 1: Use of mediNiK in the removal of kidney stones
Group 2: Standard treatment for the removal of kidney stones
Sponsors
Purenum GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged = 18 years experiencing kidney stone disease 2. Ability to read, write and speak German 3. Females with childbearing potential must have a negative serum pregnancy test at baseline and must agree to use a highly effective method of contraception for the duration of the clinical investigation. 4. Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial prior to any trial-related activity and that all information has been understood
Exclusion criteria
Exclusion criteria: 1. Participation in any other clinical trial regarding kidney stone retrieval for the past 6 months 2. Subjects with known or suspected disorders: coagulation disorders, untreated urinary tract infections, kidney disease sepsis and pronounced prostate hyperplasia 3. Subjects with a history of GU cancer that have not been at least 2 years in remission 4. Subjects with a solitary renal unit, horseshoe kidney or other anatomical anomalies which could increase subjects risk 5. Subjects with untreated ureteral stricture or UPJ or UVJ obstructions 6. Subjects with history of renal function compromise or who are on dialysis 7. Subjects with chronic hydronephrosis unrelated to obstruction from their stone disease 8. Subjects with any other illness or circumstance that could affect the trial purpose in the opinion of the investigator (e.g. bleeding that restricts vision in kidney, kidney canal system problems) 9. Subjects on anticoagulant medication 10. Subjects under medical explusive therapy (MET), e.g. alpha blockers 11. Breastfeeding or pregnant women 12. Subjects who may comprise part of a vulnerable subject population (such as prisoners or developmentally delayed adults
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To examine the safety and performance of mediNiK in removal of kidney stones in comparison to Standard of Care (SOC) | — |
Secondary
| Measure | Time frame |
|---|---|
| • To examine the performance of mediNiK compared to SOC • To examine the impact of mediNiK on the ease of kidney stone removal • Pre- and postoperative centralized CT assessment • Investigator’s opinion on ease of kidney stone removal | — |
Countries
Germany
Contacts
Public ContactThomas Amiel
Urologische Klinik und Poliklinik der Technischen Universität München
Outcome results
None listed