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:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT02881112
Eligibility Criteria:
Inclusion Criteria:
1. Subject age is greater than or equal to 22 years.
2. Subject has pain (chronic or acute) and/or edema that the prescriber deems treatment with Provant is warranted.
3. Subject is willing and able to give written informed consent.
4. Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).
Exclusion Criteria:
1. Subject requires or anticipates the need for surgery of any type during the duration of treatment.
2. Subject has received any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Screening Visit or is enrolled in another clinical trial.
3. Subject has used systemic corticosteroids within 2 months of the Screening Visit.
4. Subject has a history of a solid tumor that is not in complete remission for greater than 2 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area.
5. Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).
6. Subject has a serious psychosocial co-morbidity.
7. Subject has a history of drug or alcohol abuse within one year prior to the Screening Visit.
8. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
9. Subject is currently pregnant or planning on becoming pregnant during the treatment period.
10. Subject has been previously treated with the Provant Therapy System.
11. Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen and study visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02881112
Study Brief:
Protocol Section:
NCT02881112