Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT02366832
Eligibility Criteria:
Inclusion Criteria:
* Subjects are status post (s/p) amputation of an upper or lower limb. That is, the amputation is not congenital.
* Refractory pain symptoms, following tissue healing(postoperatively, or post injury) are related to amputation as determined by referring physician and investigator, to include: stump pain, phantom pain, unpleasant phantom sensations, and/or undesirable and/or life-limiting kinesthetic sensations. The character, frequency, location, description, and exacerbation or relieving elements will be recorded.
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.
* Positive anesthetic/steroid block, as performed under CT guidance in an analogous fashion to the cryoablation procedure.
* Absence of infection
* Absence of coagulopathy
* Ability and willingness of patient to provide written informed consent
Exclusion Criteria:
* Active infection
* Underlying congenital segmentation or other spinal anomalies that result in differential nerve root pressures
* Significant spinal stenosis interpreted as "severe" on any cross sectional imaging study
* Pregnant or planning to become pregnant
* Immunosuppression
* History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator would preclude the safe performance of cryoablation.
* Uncorrectable coagulopathies
* Concurrent participation in another investigational trial involving systemic administration of agents or within the previous 30 days.
* Have undergone a previous surgical intervention - post amputation - that may have altered the target nerve.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02366832
Study Brief:
Protocol Section:
NCT02366832