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:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT03255733
Eligibility Criteria:
Inclusion Criteria:
* Chronic Pain (\>90 days) from previously diagnosed Lateral Epicondylitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
* No History of surgery to the affected anatomy.
* No alternative treatment procedures within the last 90 days.
* Unilateral Pain
* Willingness to complete treatment and post treatment regimen as described.
* Patients who have provided written and verbal informed consent.
Exclusion Criteria:
* Patients currently enrolled in any other non-conservative, device, or Investigational New Device (IND) clinical trial, or who have participated in a clinical study involving the Common Extensor Tendon, thirty days prior to study initiation;
* Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
* Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
* At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03255733
Study Brief:
Protocol Section:
NCT03255733