ClinicalTrials.gg
RecruitingNCT06163313Updated Dec 8, 2023

Protocol No. 2016 - Calculosis- Endourology;

An observational study in Calculosis, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Started Sep 2016; still recruiting 10 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15,000
Ages
18 Years and older
Sex
All
01

Study summary

Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.

Read the detailed description

Clinical data will be collected from patients suffering from kidney stones before and after surgery, in order to demonstrate how the endoscopic approach can not only be effective in treating kidney stones but also reduce operative complications.

These data will be collected in a database in order to be able to perform statistical analyzes useful for demonstrating our theory.

Furthermore, data from the surgery will be collected regarding the endoscopic instruments used and the intraoperative findings (site, size, appearance of the stone), degree of calcification of the renal papillae.

All this in order to improve the therapeutic approach to patients suffering from stones and reduce the risk of recurrence over time through the identification of genetic expression patterns that predispose to the expression of the stone phenotype.

02

Conditions studied

  • Calculosis

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Keywords

  • calculosis
  • calculi
  • endourologia
03

In context

Lithiasis

11 studies on the registry are indexed under Lithiasis; 2 are open to participants now.

Browse Lithiasis studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients suffering from kidney stones who undergo endoscopic surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • subjects suffering from kidney stones or tumors of the upper excretory tract >= 18 years
  • signature of

Exclusion criteria

Exclusion Criteria:

  • subjects \< 18 years
  • presence of mental or physical disability that may prevent the patient from answering the questionnaires.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Calculosis patients

    Patients suffering from kidney stones

    Other: Observation of patients suffering from kidney stones who undergo endoscopic surgery

Interventions

  • OtherObservation of patients suffering from kidney stones who undergo endoscopic surgery

    Clinical data will therefore be acquired through a collection of medical history, physical examination, blood chemistry and instrumental test reports;

06

What researchers measure

Primary outcomes

  1. Clinical data

    Medical history: patient's medical history, past surgical history, family medical history, social history, allergies, and medications; physical examination: vital signs, temperature examination, blood pressure, pulse, and respiratory rate blood chemistry and instrumental test reports: Serum PSA levels, conventional imaging

    Time frame: Baseline and after 6 months

  2. Eating habits

    Eating habits through an ad-hoc eating habits questionnaire

    Time frame: Baseline and after 6 months

  3. Prostatic Function

    Prostatic Function through the International Prostatic Symptoms Score questionnaire, IPSS, Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms.

    Time frame: Baseline and after 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06163313
Lead sponsor
IRCCS San Raffaele
Responsible party
Andrea Salonia (Professor, IRCCS San Raffaele) — Principal investigator
First posted
Dec 8, 2023
Start date
Sep 17, 2016
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2066 (estimated)
Last update
Dec 8, 2023

Study contacts

Andrea Salonia, MD
Contact
salonia.andrea@hsr.it
02 2643 5661
Alessia d'Arma, MSc
Contact
darma.alessia@hsr.it
02 2643 5506
Andrea Salonia, MD
principal investigator · IRCCS Ospedale San Raffaele

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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