ChiCTR-TRC-09000733 版本V1.0 版本创建时间2015/07/09 10:08:01 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-TRC-09000733 

最近更新日期：

Date of Last Refreshed on：

 2015-06-04 13:26:15 

注册时间：

Date of Registration：

 2009-08-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

CUHK_CCT00191

申请注册联系人：

Prof. Chi Fai Ng 

研究负责人：

Lo Kin Yin Anthony 

Applicant：

Prof. Chi Fai Ng 

Study leader：

Lo Kin Yin Anthony 

申请注册联系人电话：

Applicant telephone：

 +852 26322625

研究负责人电话：

Study leader's
telephone：

+852 26323186

申请注册联系人传真 ：

Applicant Fax：

 +852 26377974

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 ngcf@surgery.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 anthonylo@surgery.cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00191

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00191

申请注册联系人通讯地址：

Department of Surgery, The Chinese Uinversity of Hong Kong

研究负责人通讯地址：

Department of Surgery, The Chinese Uinversity of Hong Kong

Applicant address：

Department of Surgery, The Chinese Uinversity of Hong Kong

Study leader's address：

Department of Surgery, The Chinese Uinversity of Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Chinese University of Hong Kong

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 NA

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Chinese University of Hong Kong

Name of the ethic committee：

Chinese University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2009-07-07 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Department of Surgery, The Chinese Uinversity of Hong Kong

Primary sponsor's address：

Department of Surgery, The Chinese Uinversity of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

The Chinese University of Hong Kong

Source(s) of funding：

The Chinese University of Hong Kong

研究疾病：

Renal stone  

Target disease：

Renal stone

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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  

Objectives of 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

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

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.

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.

排除标准：

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

Exclusion criteria：

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

研究实施时间：

Study execute time：

从 From 2009-08-15 00:00:00至 To 2012-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2009-08-15 00:00:00 至 To 2012-12-31 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 90

Group：

Two groups

Sample size：

干预措施：

Extracoroperal shock wave lithotripsy 30minutes(2Hz) / 60minutes(1Hz) Shockwave delivery rate at 1Hz/ 2Hz

干预措施代码：

Intervention：

Extracoroperal shock wave lithotripsy 30minutes(2Hz) / 60minutes(1Hz) Shockwave delivery rate at 1Hz/ 2Hz

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Chinese University of Hong Kong 

单位级别：

 Chinese University of Hong Kong 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

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

指标类型：

主要指标

Outcome：

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

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

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

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

暂停或中断

Suspending

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Randomized; Dose comparison; Open label; Crossover design.

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomized; Dose comparison; Open label; Crossover design.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Open label

Blinding：

Open label

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2015-06-04 13:26:15