Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041886
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-07-18
Brief Title:
Radiofrequency Ablation of Painful Soft Tissue Neoplasms
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Radiofrequency Ablation of Painful Soft Tissue Neoplasms
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Radiofrequency ablation is used to treat patients with many different conditions It is used to treat heart arrhythmia and benign bone tumors and to control bleeding during surgery It has been approved by the Food and Drug Administration for soft tissue ablation removal The technique involves inserting a probe guided by computed tomography or ultrasound and sending radio waves through the probe The radio waves generate heat which both destroys adjacent tissue and cauterizes blood vessels
This study will enroll 15 adults age 18 or older with soft tissue metastases who suffer pain that is not well controlled by other means such as drugs The goal is to reduce their pain or their use of analgesics by partially destroying some of their tumors
Patients will be ineligible for the study if they change the class of pain medication they use within 2 weeks before or 2 weeks after the study treatment Patients will fill out short questionnaires about pain and daily activities Brief Pain Inventory before treatment and 1 day 1 week 1 month 3 months and 12 months after treatment to ascertain whether their pain is better controlled with less pain medication
For the treatment most patients will receive local anesthetic in the area where the probe is inserted Some patients may require general anesthesia The probe will remain in place typically for 10 to 30 minutes For larger tumors it may be inserted at different positions
This study will enroll 15 adults age 18 or older with soft tissue metastases who suffer pain that is not well controlled by other means such as drugs The goal is to reduce their pain or their use of analgesics by partially destroying some of their tumors
Patients will be ineligible for the study if they change the class of pain medication they use within 2 weeks before or 2 weeks after the study treatment Patients will fill out short questionnaires about pain and daily activities Brief Pain Inventory before treatment and 1 day 1 week 1 month 3 months and 12 months after treatment to ascertain whether their pain is better controlled with less pain medication
For the treatment most patients will receive local anesthetic in the area where the probe is inserted Some patients may require general anesthesia The probe will remain in place typically for 10 to 30 minutes For larger tumors it may be inserted at different positions
Detailed Description:
This study will examine the efficacy of using radiofrequency ablation RFA to treat pain soft tissue metastases not well controlled by conventional methods of treatment defined as ongoing pain despite maximum pharmacologic interventions or severe side effects like mental status alteration from medication Prior experience with similar techniques in the liver kidney heart bones prostate lymph nodes brain pancreas and nerve ganglions has found that ablation of a specific volume of tissue with the application of RFA energy is safe and effective We are hopeful that this method of tissue ablation could assist in the difficult management of patients with painful lesions The goal will be to reduce pain or to reduce use of analgesics Any decrease in strength of opiate used or in dose equivalent same-medication on a per week basis will be considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CC-0244 | None | None | None |