A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04014478|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Pancreas Cancer Stomach Cancer Bile Duct Cancer||Device: Endovascular Denervation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain|
|Estimated Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||July 15, 2021|
|Estimated Study Completion Date :||July 15, 2021|
|Experimental: Endovascular Denervation||
Device: Endovascular Denervation
A radiofrequency ablation catheter will be placed in abdominal aorta. At least 6 sites will be ablated with settings of temerature at 60 degree centigrade and time at 120 seconds.
- Visual Analog Scale Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]Pain scale is evaluated as Woodforde Visual Analig Scale (VAS) method. The scale is from 0 to 10, with 0 being no pain, and 10 being unbearable pain.
- Morphine Equivalent Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]All analgesics used will be calculated to Morphine Equivalent using published conversion factors.
- Quality of Life Score Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]Qulaity of Life Scores are obtained using Functional Assessment of Cancer Theray-Generic Scale (FACT-G) (v 4.0) sale. The score is from 0 to 108, with 0 being no quality of life, and 108 being highest quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014478
|Contact: Hua Qing Yin, PhDfirstname.lastname@example.org|
|Study Chair:||Gao-Jun Teng, MD||Southeast University Affiliated Zhongda Hospital|
|Principal Investigator:||zhong-Min Wang, MD||Shanghai JiaoTong University Affiliated RuiJin Hospital|
|Principal Investigator:||Jian Wang, MD||Beijing University Affiliated the First Hospital|
|Principal Investigator:||Wen-Tao Li, MD||Fudan University Affiliated Cancer Hospital|
|Principal Investigator:||Chuan-Sheng Zheng, MD||HuaZhong University of Science and Technology Affiliated Union Hospital|
|Principal Investigator:||Wei-Fu Lv, MD||China University of Science and Technology Affiliated the First Hospital|
|Principal Investigator:||Jun-Hui Sun, MD||Zhejiang University Affiliated the First Hospital|
|Principal Investigator:||Hao Xu, MD||XuZhou Medical College Affiliated Hospital|
|Principal Investigator:||Ming Huang, MD||Yunnan Provincial Cancer Hospital|
|Principal Investigator:||Li-Gong Lu, MD||The People's Hospital of Zhuhai City|
|Principal Investigator:||Jian-Song Ji, MD||The Central Hospital of Lishui City|