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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT06240260
Eligibility Criteria:
Inclusion Criteria:
1. Persons with a uterus desiring insertion of intrauterine device
2. Able to provide informed consent/assent
3. Age 12-50 years old
4. Minors 12 years of age and older will be included in the study if postmenarchal
Exclusion Criteria:
1. Unable to provide informed consent/assent
2. Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
3. Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
4. Cutaneous damage at the TENS electrode sites
5. Chronic or pre-procedure use of opioids
6. Chronic pain diagnosis
7. Prior IUD insertion
8. Any contraindication to intrauterine device (IUD):
1. Pregnancy
2. Uterine anomaly that distorts the uterine cavity
3. Acute pelvic inflammatory disease (PID)
4. Postpartum endometritis or infected abortion in the past 3 months
5. Unexplained abnormal uterine bleeding
6. Wilson's disease or copper allergy (contraindication to copper IUD only)
7. Breast cancer (contraindication to levonorgestrel IUD only
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
50 Years
Study:
NCT06240260
Study Brief:
Protocol Section:
NCT06240260