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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The purpose of this study is to determine if treatment with percutaneous cryoablation yields significant differences in the evaluative criteria of Phantom Limb Syndrome (PLS).
This study aims to treat Phantom Limb Syndrome (PLS) with cryoablation of the remaining nerve stumps. The rationale is that because the pain in PLS follows the known distribution of nerves, and because the amputated nerves are known to undergo changes after the surgery that may lead to excessive "firing," that interruption of the nerve impulses will reduce patient pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Experimental | Amputee subjects experiencing phantom limb syndrome (PLS) will receive cryoablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Procedure | Subjects who respond to lidocaine nerve block will undergo CT guided cryoablation of the affected nerve stump with a 17g Galil Medical Ice Sphere cryoablation needle. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully | Feasibility, defined by number of participants, in which cryoablation was performed successfully | Post-Cryoablation |
| Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs). | Safety is measured by the number of subjects that had cryoablation procedure events (CPEs). CPEs are device- or procedure-related serious adverse events (SAE) or adverse events (AE) categorized as clinical signs or symptoms of infection (fever), hemorrhage (pain, imaging changes), nerve pain worsening, or toxicity of any kind (confusion, seizure). | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain scores on visual analogue scale (VAS ) | Change in pain score will be calculated by subtracting the day 56 pain score from the baseline pain score.The pain scores are on a continuous visual analogue scale of 0 to 100 mm. 0 mm = no pain and 100 mm = worst possible pain. The VAS is scored simply by measuring the distance, in mm, from the patient's mark to one of the ends of the line. | Baseline, day 56 |
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Inclusion Criteria:
Patients will be questioned as to the location of their sensation, be it pain, movement, burning, tingling, or other. The location of their pain will be correlated with the corresponding proximal nerve stump.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D Prologo, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
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| Label | URL |
|---|---|
| YouTube Video | View source |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
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| 17g Galil Medical Ice Sphere cryoablation needle | Device | Under CT guidance, the corresponding nerve will be targeted with a 17g probe. Two freeze-thaw cycles will be undertaken. The probe will be removed and a final scan obtained. |
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| Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ) | Quality of life will be measured using Roland-Morris Disability Questionnaire (RDQ); it is a validated measure of physical disability due to low back pain.The best score is 0 (no disability) and worst is 24 (maximum disability). | Baseline, day 56 |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |