Bariatric Surgery CandidatePEACHNCT04754893
Postbariatric EArly Discharge Controlled by Healthdot
A study testing Healthdot application in people with Bariatric Surgery Candidate, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial 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 care bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Healthdot application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Feb 2021to 25 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postbariatric EArly Discharge Controlled by Healthdot (PEACH)
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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Healthdot application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthdot applicationDevice
Healthdot device is applied on subject's chest after surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Healthdot directly after surgery and leave the hospital on the same day (evening) (group A) Receives: Device: Healthdot application |
| Group b | No intervention | Standard of care by staying one night in the hospital before returning home (group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality will be determined from the patient medical record
Measured: Within 30 days after primary surgery
Severe postoperative complications (Clavien-Dindo IIIb or higher)
Severe postoperative complications will be determined from the patient medical record
Measured: Within 30 days after primary surgery
Readmission (at least one night in hospital)
Readmission will be determined from the patient medical record
Measured: Within 30 days after primary surgery
Mild complications (Clavien-Dindo II and IIIa)
Mild complications will be determined from the patient medical record
Measured: Within 30 days after primary surgery
Prolonged length of stay (3 days or more in hospital)
Prolonged length of stay will be determined from the patient medical record
Measured: Within 30 days after primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start22 Feb 2021
- Primary completion25 Dec 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Nienhuijs, Principal investigator, Catharina Hospital, Eindhoven, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754893
- Sponsor's protocol ID
- ICBE-2-36455
- Acronym
- PEACH
- Status last verified
- Jan 2022
- First submitted
- 12 Feb 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37415024Scheerhoorn 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.
PubMed 35063007
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postbariatric EArly Discharge Controlled by Healthdot (PEACH)
- ClinicalTrials.gov ID
- NCT04754893
- Acronym / sponsor ID
- PEACH / ICBE-2-36455
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Healthdot applicationHealthdot directly after surgery and leave the hospital on the same day (evening) (group A) |
| Group b | No intervention | –Standard of care by staying one night in the hospital before returning home (group B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthdot applicationHealthdot device is applied on subject's chest after surgery | Device | Group A |
Primary outcome
Mortality
Time frame: Within 30 days after primary surgery
Mortality will be determined from the patient medical record
Severe postoperative complications (Clavien-Dindo IIIb or higher)
Time frame: Within 30 days after primary surgery
Severe postoperative complications will be determined from the patient medical record
Readmission (at least one night in hospital)
Time frame: Within 30 days after primary surgery
Readmission will be determined from the patient medical record
Mild complications (Clavien-Dindo II and IIIa)
Time frame: Within 30 days after primary surgery
Mild complications will be determined from the patient medical record
Prolonged length of stay (3 days or more in hospital)
Time frame: Within 30 days after primary surgery
Prolonged length of stay will be determined from the patient medical record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 37415024van 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.
- Derived from this study: PubMed 35063007Scheerhoorn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Nienhuijs principal investigator
Catharina Hospital, Eindhoven, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthdot application in people with Bariatric Surgery Candidate, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Within 30 days after primary surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.