Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00510

2 Trial Registration Date

2016-05-09

i Registration Status

Prospective

3 Secondary IDs

CRE-2016.071-T

4 Source(s) of Funding

University funding (The Chinese University of Hong Kong)

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ng Chi Fai

ii Address

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

iii Phone

3505 1663

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

NG CHI FAI

ii Address

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

iii Phone

3505 2625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

Department of Surgery

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

Effect of focal zone size on ESWL outcome

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

Effect of focal zone size on ESWL outcome

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-04-04

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2016.071-T

14 Medical Condition Being Studied

Renal calculi

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

extracorporeal shockwave lithotripsy with an extended focal zone

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

1 hour

vi Frequency of the intervention

1 time

16 Comparative Treatments

i Description/ name of comparative treatments

extracorporeal shockwave lithotripsy with standard focal zone

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

1 hour

v Frequency of the comparative treatments

1 time

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

• 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

ii Exclusion Criteria

• 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

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Permuted block randomization

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Devices without drug

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-01-01

21 Target Sample Size

510

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Successful treatment at 12-weeks after one session of SWL

ii The metric or method of measurement used

NCCT

iii The timepoint(s) of primary interest

12-week

24 Secondary Outcome

i The Name of the outcome

Degree of acute renal injury

ii The metric or method of measurement used

urine level of markers

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Incidence of renal haematoma after SWL

ii The metric or method of measurement used

MRI or NCCT

iii The timepoint(s) of primary interest

Day-2

Secondary Outcome

i The Name of the outcome

Incidence of adverse events

ii The metric or method of measurement used

Clavien system

iii The timepoint(s) of primary interest

within 30 days

Secondary Outcome

i The Name of the outcome

Pain experienced by patients during treatment

ii The metric or method of measurement used

10 cm visual analogue scale

iii The timepoint(s) of primary interest

immediate after SWL

Secondary Outcome

i The Name of the outcome

The total analgesia consumed

ii The metric or method of measurement used

patient controlled analgesic system

iii The timepoint(s) of primary interest

immediate after SWL

Secondary Outcome

i The Name of the outcome

Stone free rate

ii The metric or method of measurement used

NCCT

iii The timepoint(s) of primary interest

12-week

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2023-03-24

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-16008475

28 Date of Registration in Primary Registry

2016-05-09

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Trial History Detail on 2019-03-20