Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope

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

Comprehensive comparative investigations between HugeMed HU30M 6.3 Fr f-URS and traditional approach f-URS devices in RIRS are lacking in an American population. The investigators aim to compare the outcomes of using the 6.3 Fr f-URS versus traditional approach (other f-URS present in our institution) to treat patients with stone burden ≤ 2.5 cm. The findings of this study will expand on the potential advantages and drawbacks of HU30M in enhancing surgical outcomes and patient safety in RIRS procedures. We hypothesize that the use of the HU30M will result in increased cost savings while providing similar stone free rates when compared to traditionally used f-URS devices.

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

• Males or females ≥ 18 years of age

• Patients with ureteral or kidney stones undergoing primary flexible ureteroscopy for retrograde intrarenal surgery

• Total stone burden ≤ 2.5 cm

Locations
United States
Kansas
University Of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Wilson R. Molina, MD
wmolina@kumc.edu
913-588-8721
Backup
Jane Research Project Manager
jledesma2@kumc.edu
913-588-8721
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2028-11
Participants
Target number of participants: 75
Treatments
Active_comparator: hugemed ureteroscopy
Patients scheduled to undergo URS retrograde intrarenal surgery per standard of care will be recruited from urology clinics or OR schedules using using the 6.3 Fr f-URS . Patients may be approached and consented in clinic or pre-op.~All procedures, devices, and ancillary equipment are standard of care. There is no additional cost to the patient, only the typical standard of care costs. Participants will not be compensated for participation in the study.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center
Collaborators: HugeMed

This content was sourced from clinicaltrials.gov

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