Lithotripsy Clinical Trials

Clinical trials related to Lithotripsy Procedure

VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures: a Post-marketing Clinical Investigation of REALICA

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Though the efficacy of VRH is documented in various outpatient urological procedures and has provided promising preliminary information in prostate biopsy, its systematic use in urology remains poorly studied. Considering the potential of invasive urological procedures to induce significant patient discomfort, the application of innovative immersive approaches, such as those offered by medical devices, could lead to an overall clinical benefit. Among these, REALICA® (available from https://REALICA.io/en/), a class I CE medical device, widely used in hospitals and validated by numerous studies, represents a valuable resource in urology, supported by high satisfaction rates received in abdominal surgery and extracorporeal lithotripsy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Male/female with age ≥ 18 years

• Patient who are undergoing one of the interventions mentioned in the study for the first time;

• Eligibility for minimally invasive ambulatory urological procedures, possibly requiring vascular access (circumcision, prostate biopsy, flexible cystoscopy);

• Ability to understand instructions and complete study questionnaires;

• Signed informed consent.

Locations
Other Locations
Italy
Istituto Oncologico Veneto IRCCS
RECRUITING
Padova
Contact Information
Primary
Antonio Amodeo, MD
antonio.amodeo@iov.veneto.it
0423-421321
Backup
Gian Luca De Salvo, MD
clinical.trial@iov.veneto.it
0498215704
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 56
Treatments
Experimental: Virtual reality
REALICA® is a virtual reality viewer, designed to reduce stress and anxiety in patients during intervention and invasive procedure. This medical device effectively distracts the patient through interactive audiovisual content and promotes relaxation through guided visual and sound stimuli. The system provides in each setting for interactions designed to engage the patient's attention, consisting of simple games or activities, which require the participation of the patient through the use of the external controllers provided, who is then required to interact. The system operates anonymously, with no need to identify the patient or collect any sensitive data about the user. The device is configured as a stand-alone device, i.e., autonomous and without the need for wired connections to PCs or other external devices.
Active_comparator: Control group
Control group will be treated according to clinical practice.
Related Therapeutic Areas
Sponsors
Leads: Istituto Oncologico Veneto IRCCS

This content was sourced from clinicaltrials.gov