ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain (NCT00981578) | Clinical Trial Compass
TerminatedNot Applicable
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
Stopped: Terminated due to low enrollment.
United States37 participantsStarted 2009-09
Plain-language summary
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women age 18 and older
✓. Patients who are able and willing to give consent and able to attend all study visits
✓. Patients who are suffering from symptoms of bone metastases
✓. One to 3 painful lesions.
✓. Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)
✓. Patients with persistent distinguishable pain associated with up to 3 tumors of which a maximum of 2 tumors will be treated:
✓. Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ≥ 4) irrespective of medication
✓. Targeted tumors (most painful) size up to 8 cm in diameter
Exclusion criteria
✕. Patients who either
✕. More than 3 painful lesions or more than 2 requiring immediate localized treatment
✕. The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS.