Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope
A Prospective Randomized Study Comparing Single-use Digital Flexible Ureteroscope, Nondisposable Fiber Optic and Digital Ureteroscope in Treatment of Upper Urinary Stone Less Than 2 cm
1 other identifier
interventional
450
0 countries
N/A
Brief Summary
The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJuly 18, 2017
July 1, 2017
3.1 years
July 1, 2017
July 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
cost of surgery
the total cost of the procedure
intraoperative
Secondary Outcomes (5)
Stone free rate
1month after surgery
stone free rate
3months after surgery
complication rates
upto 3months
operative time
intraoperative
operator's satisfaction with the scope
intraoperative
Study Arms (3)
single-use digital ureteroscope
EXPERIMENTALParticipants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope.
reusable fiberoptic ureteroscopes
EXPERIMENTALParticipants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope
reusable digital flexible ureteroscopes
EXPERIMENTALParticipants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope.
Interventions
All participants in this arm will undergo RIRS using a single use digital ureteroscope.
All participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope
All participants under this arm will undergo RIRS using reusable digital flexible ureteroscope
Eligibility Criteria
You may qualify if:
- Aged 18-70 years
- American society of Anesthesiology (ASA) score 1 and 2
- Renal or upper ureteral stone of diameter ≤ 2.0 cm
You may not qualify if:
- Ureteral stricture, renal or ureteral deformity
- Pregnancy
- Patients with chronic kidney disease, CKD (serum creatine\> 177 umol/L)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guohua Zenglead
- Dr. Lufti KIRDAR Kartal Research and training Hospital, Instanbul, Turkeycollaborator
- Siloam St.Trudpert Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor and Proffesor
Study Record Dates
First Submitted
July 1, 2017
First Posted
July 18, 2017
Study Start
August 1, 2017
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
July 18, 2017
Record last verified: 2017-07