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Trial History Detail on 2017-03-18

CUHK_CCT00462

2015-07-03

Prospective

CRE-2015.045-T

General Research Fund (GRF)

University Grants Committee

The Chinese University of Hong Kong

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Ng Chi Fai

4/F., LCW Clinical science building, Prince of Wales Hospital, Shatin

2632 1663

ngcf@surgery.cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Ng Chi Fai

4/F., LCW Clinical science building, Prince of Wales Hospital, Shatin

2632 1663

ngcf@surgery.cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

A prospective randomized study to investigate the effect of stepwise voltage escalation on treatment outcome in extracorporeal shockwave lithotripsy of renal calculi

Effect of voltage ramping on ESWL outcome

能量逐步遞增治療方案對體外碎石沖擊波治療腎結石成效的前瞻性隨機研究

Effect of voltage ramping on ESWL outcome

Hong Kong

Yes

2015-04-10

Joint CUHK-NTEC Clinical Research Ethics Committee

CRE-2015.045-T

Renal calculi

Procedure

Stepwise voltage escalation on extracorporeal shockwave lithotripsy

NA

NA

1 hour

1 time

Standard protocol of extracorporeal shockwave lithotripsy

NA

NA

1 hour

1 time

• Adult patient (aged ≥ 18 years old).
• Solitary radio-opaque renal stones of size 5-15mm in maximal diameter as measured from NCCT.
• Clear clinical indication for primary SWL

• Stones associated with any renal or ureteric anatomical abnormality, such as caliceal diverticulum, horseshoe kidney, ureteropelvic junction obstruction etc
• Patients with ureteric stent or nephrostomy tube inserted
• Patients with known history of cystine stone.
• Patients with multiple stones in the same calyx.
• Patients with history of allergy or any abnormal reaction with alfentanil

18

999

Both Male and Female

Interventional

Randomized

Permuted block randomization

Active

Single-blind

Trial subjects

Parallel

Other

Devices without drug

2016-02-01

300

Recruiting

Successful treatment at 12-weeks after one section of SWL

• Degree of renal injury
• Incidence of renal haematoma developed after SWL
• Post-treatment pain score and the total analgesics consumption
• Incidence of adverse events
• Stone Free rate

No

2019-03-20

ChiCTR-IOR-15006698 

2015-07-03

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