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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT02003404
Eligibility Criteria:
Inclusion Criteria:
* Colostomy, Ileostomy, or Urostomy patients at least 6 months post-surgery
* Males or females, age 18 to 80 years old at the time of enrollment
* Body Mass Index (BMI) between 18 and 50
* Willing to have two approximately 5" x 5" areas of the abdomen trimmed with a surgical clipper -- one in a ring around the stoma, and one on the opposite side
* Willing to remain within the testing room for the duration of the study
* Willing to allow a third person in the room as a witness for the duration of the study
* Able to position oneself onto and off of the examining table without the assistance of the Investigator
* Willing to refrain from vigorous exercise for the duration of the study
* Willing to not take any anti-inflammatory medications (except for Tylenol/acetaminophen) starting 48 hours prior to the study and for the duration of the study
* Willing to bring an extra barrier and replace their barrier worn during the study.
* Willing to follow the protocol as demonstrated by signing the Informed Consent Form
* In the opinion of the Investigator or qualified site personnel is qualified to participate
Exclusion Criteria:
* Clinically significant diseases, which may or may not be confined to the testing site, that may contraindicate participation; including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
* Use of topical drugs on the application site within 1 month.
* Use of lotions, creams, powders or oils on the application site in the 24 hours prior to application
* Pregnancy, lactation or planning a pregnancy as determined by interview only
* Other medical conditions, for example uncontrolled diabetes, which in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk
* Participation in any clinical test either using the abdomen as a test site or using systemic therapy within the previous thirty days
* Damaged skin or other skin conditions in or near test sites which includes sunburn, scars, numerous moles or other disfiguration of the test site
* Significant adipose tissue at the test site that would preclude adequate adhesion of the study devices
* Known allergy to any of the test materials
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02003404
Study Brief:
Protocol Section:
NCT02003404