Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00191

2 Trial Registration Date

2009-08-07

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Prof. Chi Fai Ng

ii Address

Department of Surgery, The Chinese Uinversity of Hong Kong

iii Phone

Tel: 26322625; Fax: 26377974

iv Email

Email: ngcf@surgery.cuhk.edu.hk

v Affiliation

Department of Surgery, The Chinese University of Hong Kong

vi Country

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

i Name

Lo Kin Yin Anthony

ii Address

Department of Surgery, The Chinese Uinversity of Hong Kong

iii Phone

Tel: 26323186;

iv Email

Email: anthonylo@surgery.cuhk.edu.hk

v Affiliation

Department of Surgery, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

The impact of 60 verse 120 shock wave per minute on treatment outcome, renal injury and patients’ perception to pain in extracorporeal shock wave lithotripsy for renal calculi: a randomized crossover clinical study

10 Public Title

The impact of shock wave delivery rate on treatment outcome, renal injury and patients’ perception to pain in extracorporeal shock wave lithotripsy

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

The role of shockwave delivery rate in extracorporeal shockwave lithotripsy

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2009-07-07

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

Device

Please specify

ii Description/ name of Intervention/article

Extracoroperal shock wave lithotripsy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30minutes(2Hz) / 60minutes(1Hz)

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Shockwave delivery rate at 1Hz/ 2Hz

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

Inclusion Criteria:
1. Adult patient (aged ≥ 18 years old).
2. The targeted stone / stone fragments is remained in the same position
3. Clinically decided for repeated SWL for the residual stone

ii Exclusion Criteria

Exclusion Criteria:
1. Patients with ureteric stent or nephrostomy tube inserted.
2. Patient with history of allergy or any abnormal reaction alfentanil

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Crossover

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2009-08-15

21 Target Sample Size

90

22 Recruitment Status

Complete

23 Primary Outcome

Stone free or presence of clincially insignificant residual fragments (less than 4 mm), at 12 weeks after the second session of lithotripsy.

24 Secondary Outcome

1. Change in urine level of NAG, NGAL and IL-18 at pre-treatment and at Day-2, Day-7, 4-weeks after the second session of lithotripsy treatment.
2. Maximum pain score During lithotripsy treatment
3. Dosage of analgesia used during SWL At the end of treatment
4. Patients' preference to the shockwave delivery rate At the end of treatment

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-09000733

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2012-04-03