Status:
COMPLETED
Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent.
Lead Sponsor:
Devicare S.L.
Collaborating Sponsors:
Clever Instruments S.L.
Conditions:
Stent Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the effectivity in urinary pH Control and the prevention of calcification in Double J stent using a device combined with the intake of dietary supplements. Every patient will rece...
Detailed Description
Several studies have shown the importance of urinary pH Control (pHv) to determine the frequency of stent incrustation, this measure being a variable to be taken into account in the management of cath...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- Patients which have been recently implanted a Double J stent (less than a week implant) or who have planned their implant and have been recommended with pH control to avoid incrustation/calcification.
- Patients who accept their participation in the study and give their informed consent
Exclusion
- Patients with base pathologies wich , based on clinical criteria, aren´t sensitive about the study dietary supplement indications.
- Patients which have programmed the stent extraction 3 weeks before base visit.
- Uric and cystinuric patients which requires pH control different from the established study protocol .
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2018
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03343275
Start Date
December 13 2017
End Date
July 9 2018
Last Update
July 11 2018
Active Locations (9)
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1
Hospital Universitario de Valme
Seville, Andalusia, Spain
2
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
3
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, Spain, 15706
4
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312