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Clinical Trials/CTRI/2023/04/051704
CTRI/2023/04/051704CompletedPhase 4

Safety and efficacy of thulium fiber laser versus pneumatic lithotripsy for ureteric stones using semi rigid ureteroscopy

Sai Urology Hospital1 site in 1 country100 target enrollmentStarted: April 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Safety and efficacy of Thulium fiber laser versus pneumatic lithotripsy

Study Overview

Brief Summary

Thulium fiber laser is a novel technology used for stone lithotripsy. Because of it’s excellent dusting properties it has the potential to become ideal laser for stone treatment. There is a concern of heat generation and potential trauma to the renal and ureteral mucosa during the use of lasers in renal and ureteral stone treatment. Special concern is for the ureteric stone as the lumen is narrow and the stones are usually impacted. Pneumatic lithotripsy is the standard energy source used for ureteral stone treatment.  We hence propose to evaluate the Safety and efficacy of thulium fiber laser versus Pneumatic Lithotripsy for ureteric stones using semi rigid ureteroscopy

Primary Objective: Safety & efficacy of laser and pneumatic energy source

Secondary Objective: Immediate & long term complications

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
5.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •All sexes with age ranging from 5- 75 years Patients having clinical and radiological diagnosis of ureteric calculi.

Exclusion Criteria

  • •Pregnancy Coagulopathy Pyonephrosis Combined renal and ureteric stone.

Outcomes

Primary Outcomes

Safety and efficacy of Thulium fiber laser versus pneumatic lithotripsy

Time Frame: Baseline, 7 days, 30 days, 180 days

Secondary Outcomes

  • Immediate and long term complications(6 months)

Investigators

Sponsor
Sai Urology Hospital
Sponsor Class
Private hospital/clinic

Study Sites (1)

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