Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 4:02 AM
Study NCT ID:
NCT04754893
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2021-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postbariatric EArly Discharge Controlled by Healthdot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Within 30 days after primary surgery', 'description': 'Mortality will be determined from the patient medical record'}, {'measure': 'Severe postoperative complications (Clavien-Dindo IIIb or higher)', 'timeFrame': 'Within 30 days after primary surgery', 'description': 'Severe postoperative complications will be determined from the patient medical record'}, {'measure': 'Readmission (at least one night in hospital)', 'timeFrame': 'Within 30 days after primary surgery', 'description': 'Readmission will be determined from the patient medical record'}, {'measure': 'Mild complications (Clavien-Dindo II and IIIa)', 'timeFrame': 'Within 30 days after primary surgery', 'description': 'Mild complications will be determined from the patient medical record'}, {'measure': 'Prolonged length of stay (3 days or more in hospital)', 'timeFrame': 'Within 30 days after primary surgery', 'description': 'Prolonged length of stay will be determined from the patient medical record'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery Candidate']}, 'referencesModule': {'references': [{'pmid': '37415024', 'type': 'DERIVED', 'citation': 'van Ede ES, Scheerhoorn J, Schonck FMJF, van der Stam JA, Buise MP, Nienhuijs SW, Bouwman RA. Lessons Learned from Telemonitoring in an Outpatient Bariatric Surgery Pathway-Secondary Outcomes of a Patient Preference Clinical Trial. Obes Surg. 2023 Sep;33(9):2725-2733. doi: 10.1007/s11695-023-06637-9. Epub 2023 Jul 7.'}, {'pmid': '35063007', 'type': 'DERIVED', 'citation': 'Scheerhoorn J, van Ede L, Luyer MDP, Buise MP, Bouwman RA, Nienhuijs SW. Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial. Trials. 2022 Jan 21;23(1):67. doi: 10.1186/s13063-022-06001-9.'}]}, 'descriptionModule': {'briefSummary': '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 care bariatric surgery. The difference between both recovery paths is that half of the patients will get the standard of care by staying one night in the hospital before returning home (group B), while the other half will receive a Healthdot directly after surgery and leave the hospital on the same day (evening) (group A). 200 patients will be recruited and can choose whether they want to be assigned to the the regular recovery path or receive a Healthdot and leave the hospital on the same day. If they have no preference they will be randomly assigned to one of the two groups. Patients in the outpatient recovery group will wear the Healthdot for 7 days at home and vital signs (heart rate and respiratory rate, together with context data on activity and posture) will be transmitted to the hospital to monitor recovery. The study is mainly designed to investigate if the clinical outcome in both groups is equal (non-inferiority) based on a combined outcome measures like 30 days readmission rate and patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (equal or above 18)\n* Approval for primary bariatric surgery (gastric sleeve or bypass) by a multidisciplinary bariatric team\n* Willing and able to sign informed consent form\n* Able to understand instructions\n* In possession of a telephone on which patient can be reached for the duration of participation (day 1-8)\n* 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.\n\nExclusion Criteria:\n\n* Patients of psychiatric wards, inmates of prisons, or other state institutions\n* Investigator or any other team member involved directly or indirectly in the conduct of the clinical study\n* 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\n* Known allergy for the tissue adhesive used in the Healthdot (white band-aid)\n* Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions)\n* Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker\n* Expected participation less than 8 days\n* 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.\n* Patients with antibiotic resitant infections (e.g. MRSA)'}, 'identificationModule': {'nctId': 'NCT04754893', 'acronym': 'PEACH', 'briefTitle': 'Postbariatric EArly Discharge Controlled by Healthdot', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Electronics Nederland B.V. acting through Philips CTO organization'}, 'officialTitle': 'Postbariatric EArly Discharge Controlled by Healthdot (PEACH)', 'orgStudyIdInfo': {'id': 'ICBE-2-36455'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Healthdot directly after surgery and leave the hospital on the same day (evening) (group A)', 'interventionNames': ['Device: Healthdot application']}, {'type': 'NO_INTERVENTION', 'label': 'Group b', 'description': 'Standard of care by staying one night in the hospital before returning home (group B)'}], 'interventions': [{'name': 'Healthdot application', 'type': 'DEVICE', 'description': "Healthdot device is applied on subject's chest after surgery", 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'overallOfficials': [{'name': 'Simon Nienhuijs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catharina Hospital, Eindhoven, The Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Electronics Nederland B.V. acting through Philips CTO organization', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}