Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00462

2 Trial Registration Date

2015-07-03

i Registration Status

Prospective

3 Secondary IDs

CRE-2015.045-T

4 Source(s) of Funding

General Research Fund (GRF)

5 Primary Sponsor

University Grants Committee

6 Secondary Sponsor

The Chinese University of Hong Kong

Function

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

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

2632 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

2632 1663

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

Effect of voltage ramping on ESWL outcome

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

Effect of voltage ramping 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?

2015-04-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2015.045-T

14 Medical Condition Being Studied

Renal calculi

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Stepwise voltage escalation on extracorporeal shockwave lithotripsy

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

Standard protocol of extracorporeal shockwave lithotripsy

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 (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

ii Exclusion Criteria

• 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 currently taking alpha-blockers or calcium-channel blockers or systemic corticosteroids.
• Patients with history of allergy or any abnormal reaction with alfentanil

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

2016-02-01

21 Target Sample Size

300

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Successful treatment at 12-weeks after one section of SWL

24 Secondary Outcome

• 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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-03-20

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006698

28 Date of Registration in Primary Registry

2015-07-03

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Trial History Detail on 2016-02-01