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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT06979804
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing ACL or ACL+Meniscus surgery
* Age 16 - 65
* Patients with Body Mass Index (BMI) \<40
* Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
* Patients who are willing and able to sign corresponding research subject consent/assent form.
Exclusion Criteria:
* Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
* Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
* Patient has had prior surgical treatment of the knee in the last 5 years or injection treatment(s) in the last 6 months
* Patient has chronic pain conditions unrelated to knee condition
* Patient has auto-immune or auto-inflammatory diseases
* Patient has poorly controlled diabetes (HgA1c \> 7.5)
* Patient has BMI \> 39.9
* Patient has varicosities on the operative leg
* Patient has severe peripheral artery disease (ABI \< 0.6)
* Patient is considered a pain management patient
* Patient has had previous blood clots or stroke
* Patient has used tobacco within the last 90 days
* Patient is not within the ages of 16-65
* Patient has an active infection (local or systemic), or an open (non-surgical) wound in the areas of product application
* Patient is unwilling or unable to sign the corresponding research subject consent/assent form
* Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT06979804
Study Brief:
Protocol Section:
NCT06979804