Status:
COMPLETED
Postbariatric EArly Discharge Controlled by Healthdot
Lead Sponsor:
Philips Electronics Nederland B.V. acting through Philips CTO organization
Conditions:
Bariatric Surgery Candidate
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical investigation is a single center patient preference trial in a tertiary hospital in the Netherlands, designed to compare the outcome of two different recovery paths after standard of car...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2021
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04754893
Start Date
February 22 2021
End Date
December 25 2021
Last Update
June 30 2022
Active Locations (1)
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1
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623 EJ