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Trial History Detail on 2019-03-05

CUHK_CCRB00510

2016-05-09

Prospective

CRE-2016.071-T

University funding (The Chinese University of Hong Kong)

The Chinese University of Hong Kong

NA

Not Applicable

Ng Chi Fai

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

3505 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

3505 2625

ngcf@surgery.cuhk.edu.hk

Department of Surgery

Hong Kong

A randomized study to investigate the effect of focal zone size on treatment outcomes in patients undergoing extracorporeal shockwave lithotripsy to renal calculi

Effect of focal zone size on ESWL outcome

一項隨機研究探討聚焦區域大小對體外衝擊波碎石治療腎結石的治療結果的影響

Effect of focal zone size on ESWL outcome

Hong Kong

Yes

2016-04-04

Joint CUHK-NTEC Clinical Research Ethics Committee

CRE-2016.071-T

Renal calculi

Procedure

extracorporeal shockwave lithotripsy with an extended focal zone

NA

NA

1 hour

1 time

extracorporeal shockwave lithotripsy with standard focal zone

NA

NA

1 hour

1 time

• Adult patient with age greater than or equal to 18 years old

• Solitary radio-opaque renal calculi of size 5-15 mm in maximal diameter

• Clinically indicated for SWL

• Stones associated with any renal or ureteric anatomical abnormality, such as medullary spongy kidneys, caliceal diverticulum, horseshoe kidney, ureteropelvic junction obstruction

• Patients with ureteric stent or nephrostomy tube in-situ or within 3 months of SWL

• Patients with a known history of cystine stone

• Patients with multiple renal calculi within the same calyx

18

999

Both Male and Female

Interventional

Randomized

Permuted block randomization

Active

Single-blind

Trial subjects

Parallel

Other

Devices without drug

2017-01-01

510

Recruiting

Successful treatment at 12-weeks after one session of SWL

NCCT

12-week

Degree of acute renal injury

urine level of markers

post, Day-2, 6-week, 12-week

Incidence of renal haematoma after SWL

MRI or NCCT

Day-2

Incidence of adverse events

Clavien system

within 30 days

Pain experienced by patients during treatment

10 cm visual analogue scale

immediate after SWL

The total analgesia consumed

patient controlled analgesic system

immediate after SWL

Stone free rate

NCCT

12-week

No

2023-03-24

ChiCTR-INR-16008475

2016-05-09

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