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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT01704157
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 years of age and older.
* Participants must meet American College of Rheumatology (ACR) criteria for osteoarthritis of the knee (unilateral or bilateral). Clinical criteria includes knee pain and at least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, and/or no warmth to the touch.
* Any medications (prescription and/or over-the counter) must be maintained on a stable schedule for ≥ 2 weeks prior to treatment. No washout period is allowed.
* An average Visual Analog Scale (VAS) for pain ≥ 4 over the last 30 days.
* Subject is willing and able to give written informed consent.
* Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
* Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.
Exclusion Criteria:
* A partial or full knee replacement (in the treated knee).
* Any use of systemic injections (in any area) within the last 6 months.
* Current enrollment in an investigational drug or a device study that specifically targets pain treatment.
* Any additional diagnosis that in the opinion of the investigator may directly contribute to knee pain.
* Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bones disease, gout, active infection, etc.).
* Any clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
* Allergy or intolerance to lidocaine.
* Any local skin condition at the treatment site that in the investigator's opinion would adversely affect treatment or outcomes.
* Any chronic medical condition that in the investigator's opinion would prevent adequate participation.
* Any chronic medication use (prescription, over-the-counter, etc.) that in the investigator's opinion would affect study participation or subject safety.
* For any reason, in the opinion of the investigator, the subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, any related knee injury due to a worker's compensation claim, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01704157
Study Brief:
Protocol Section:
NCT01704157