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Evaluation of the HugeMed HU30M Single-Use Ureteroscope for Kidney Stone Treatment: A Prospective Clinical Study

Use of the HugeMed HU30M Single-Use Ureteroscope - Comparative Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099376
Enrollment
Unknown
Registered
2025-03-21
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stone Disease (Nephrolithiasis)

Interventions

Group 1 (Experimental Group):Flexible ureteroscopy (fURS) using the single-use 6.3 Fr ureteroscope (HugeMed HU30M) for kidney stone treatment.
Group: Standard Ureteroscope (7.5 Fr):Flexible ureteroscopy (fURS) using the standard single-use 7.5 Fr ureteroscope for kidney stone treatment

Sponsors

Saint John Emergency Clinical Hospital, Bucharest, Romania
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age <= 75 years; 2. Diagnosed with kidney stones <= 2 cm confirmed by CT; 3. Pre-stented before surgery; 4. Able to attend follow-up at 30 days.

Exclusion criteria

Exclusion criteria: 1. Presence of ureteral stones only (without kidney stones); 2. Active urinary tract infection (positive urine culture); 3. Oncological patients with urological malignancies; 4. Severe comorbidities preventing safe anesthesia or surgery; 5. Patients unable to comply with follow-up requirements.

Design outcomes

Primary

MeasureTime frame
Stone-Free Rate (SFR) at 30 Days;

Secondary

MeasureTime frame
Operative Time;Postoperative Complication Rate (Clavien-Dindo Classification);Laser Energy Consumption;

Countries

Romania

Contacts

Public ContactProf. Dr. Petrisor – Aurelian Geavlete

"Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania

geavlete@gmail.com+40 722 331 825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026