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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05348005
Eligibility Criteria:
Inclusion Criteria:
1. Females ages 18-45 years at time of enrollment
2. A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
3. Average monthly endometriosis pain flare
4. Naïve TENS user
Exclusion Criteria:
1. TENS device exclusion:
1. Implantable devices (pacemaker, Interstim, etc.)
2. Cardiac arrhythmia
3. Open skin sores over areas of placement
2. Pregnancy
3. Nursing or trying to conceive at this time
4. Post-operative \<12 weeks from abdominal or pelvic surgery
5. Planned surgery or hormonal medication changes for duration of study if applicable
6. Non-English speaking or inability to read and understand English
7. Prisoners
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05348005
Study Brief:
Protocol Section:
NCT05348005