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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT04138602
Eligibility Criteria:
Inclusion Criteria:
1. Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information.
2. Women and men, 18 years of age or older
3. Subject reported fecal incontinence
4. Up to date on screening colonoscopy per guidelines (USPSTF)
5. Willingness to comply with conservative dietary management
6. Subject agrees to maintain a stable dose of any medication, prescribed or over the counter, known to affect bowel functioning.
7. Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.
8. If of child-bearing age, agree to practice approved birth-control methods listed in appendix C
Exclusion Criteria:
1. Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
2. Subject weighs more than 330 pounds
3. Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
4. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
5. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
6. Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study
7. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
8. Currently healing from surgical procedures where muscle contraction may disrupt the healing process
9. Subject has a malignant tumor, in any location of the body
10. Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit
11. Subject has used the BTL EMSELLA device previously
12. Neurologic conditions deemed exclusionary by an investigator, including multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.
13. Chronic pelvic pain \> 4/10 VAS
14. Undiagnosed/unmanaged disorders of motility, including Irritable Bowel Syndrome (IBS)
15. Undiagnosed colorectal conditions
16. Bowel surgery in the past 12 months
17. Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit
18. Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
* To preserve the integrity of the study, some criteria have been omitted. All criteria will be available to the public at the close of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04138602
Study Brief:
Protocol Section:
NCT04138602