Trials / Unknown
UnknownNCT04014478
A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd · Industry
- Sex
- All
- Age
- 25 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, self-control clinical trial aim to enroll 110 patients suffered from upper abdominal (liver, pancreas, stomach, etc.) cancers . Patients who have taken at least one opioid drug for pain for two weeks and still have a VAS pain scale greater than 6 will receive endovascular denervation (EDN). They will be followed up for 3 months. The VAS scales, quantity of analgesics as represented by morphine equivalent and quality of life scores will be compared before and after EDN. Safety parameters such as arterial deformation, embolism, infection, liver and kidney functions will also be monitored.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-07-15
- Primary completion
- 2021-07-15
- Completion
- 2021-07-15
- First posted
- 2019-07-10
- Last updated
- 2019-07-10
Source: ClinicalTrials.gov record NCT04014478. Inclusion in this directory is not an endorsement.