Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00414

2 Trial Registration Date

2014-05-27

i Registration Status

Prospective

3 Secondary IDs

CRE-2014.096-T

4 Source(s) of Funding

Departmental

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

Function

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

iii Phone

2632 1663

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

iii Phone

2632 1663

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

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
的前瞻性研究

11 Short Title (Optional)

N/A

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?

2014-03-31

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Renal stone

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Stepwise voltage escalation in extracorporeal shockwave lithotripsy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30 - 60 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Standard fixed voltage with 30-60 minutes duration

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

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 plain radiography. Clinically decided for primary ESWL

ii Exclusion Criteria

Stones associated with renal or ureteric anatomical abnormality. Patients with ureteric stent or nephrostomy tube inserted. History of cystine stone. Multiple stones in the same calyx. Currently taking alpha-blocker or calcium-channel blocker or systemic corticosteroids. 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

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-06-15

21 Target Sample Size

220

22 Recruitment Status

Unknown

23 Primary Outcome

Treatment successfulness at 12 weeks

24 Secondary Outcome

Degree of renal injury. Maximal pain score. Analgesics consumption.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004710

28 Date of Registration in Primary Registry

2014-05-28

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-06-28