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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT04754893
Eligibility Criteria:
Inclusion Criteria:
* Adult (equal or above 18)
* Approval for primary bariatric surgery (gastric sleeve or bypass) by a multidisciplinary bariatric team
* Willing and able to sign informed consent form
* Able to understand instructions
* In possession of a telephone on which patient can be reached for the duration of participation (day 1-8)
* An adult person must be present at the same location as the patient during the first night following surgery who is able to mobilize help or seek medical care if necessary.
Exclusion Criteria:
* Patients of psychiatric wards, inmates of prisons, or other state institutions
* Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
* Any skin condition, for example prior rash, discoloration, scars or open wounds at the area (Left lower rib) where the Healthdot needs to be placed
* Known allergy for the tissue adhesive used in the Healthdot (white band-aid)
* Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions)
* Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker
* Expected participation less than 8 days
* Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
* Patients with antibiotic resitant infections (e.g. MRSA)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04754893
Study Brief:
Protocol Section:
NCT04754893