PAD - Peripheral Arterial DiseaseOBAOMINCT07082517
Observational Study of Risk Factors for Peripheral Artery Disease in Bathroom Scale Withings Body Cardio Users
An observational study of PAD - Peripheral Arterial Disease, run by Withings at 1 site in France.
Trial summary
Withings Body Cardio is capable to measure PWV in the right and left lower limbs. The hypothesis of this study is a significant difference in PWV between the right and left lower limbs measured by the device may be the sign of people with more risk factors that may lead to a PAD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PAD - Peripheral Arterial Disease
- What is being tested?
- Percentage analysis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2021to 16 Mar 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Active and regular user of the Withings Body Cardio Bathroom Scale
Who may be able to join
- Active and regular user of the device
- Adult participant
- Participant who agreed to participate in the study, after reading the study information letter
- Participant living in France
Who cannot join
- User who didn't agreed to participate to the study after reading the study information letter
Trial locations and contacts
1 site in 1 country.
About this study
Withings Body Cardio is capable to measure PWV in the right and left lower limbs. The hypothesis of this study is a significant difference in PWV between the right and left lower limbs measured by the device may be the sign of people with more risk factors that may lead to a PAD.
Read the detailed description
Active users of WITHINGS Body Cardio bathroom scale will be invited to participate to the study. In case of a positive answer, the user will receive an electronic questionnaire about its health and medical history and the data recorded from the previous six months on his/her Body Cardio bathroom scale will be collected in the study.
Once consent has been given, the user's data collectedby the WITHINGS Body Cardio scales will be extracted anonymously and associated with the answers to the questionnaire.
- Conditions
- PAD - Peripheral Arterial Disease
- Being tested
- Percentage analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percentage analysisOther
Analysis the percentage of the population with risk factors that may lead to a PAD.
| Study group | Role | What they receive |
|---|---|---|
| Significant PWV difference | Population with a significant difference PWV between the right and left lower limbs. Receives: Other: Percentage analysis | |
| No significant PWV difference | Population with no significant difference PWV between the right and left lower limbs. Receives: Other: Percentage analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the distribution of risk factors for people with a high People with significant PWV difference will be compared to people with no significant PWV difference
Chi 2 test between the two population
Measured: 1 year
Secondary outcomes (1)
Acceptability of the device
Amount of daily use of the device
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start3 Jun 2021
- Primary completion30 Nov 2021
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAD - Peripheral Arterial DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Boutouyrie, Pr, Principal investigator, Georges Pompidou European Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082517
- Sponsor's protocol ID
- 2020-A02620-39
- Acronym
- OBAOMI
- Status last verified
- Jul 2025
- First submitted
- 15 Nov 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Risk Factors for Peripheral Artery Disease in Bathroom Scale Withings Body Cardio Users
- ClinicalTrials.gov ID
- NCT07082517
- Acronym / sponsor ID
- OBAOMI / 2020-A02620-39
- Conditions
- PAD - Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 24 Jul 2025 (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.
Withings Body Cardio is capable to measure PWV in the right and left lower limbs. The hypothesis of this study is a significant difference in PWV between the right and left lower limbs measured by the device may be the sign of people with more risk factors that may lead to a PAD.
Detailed description
Active users of WITHINGS Body Cardio bathroom scale will be invited to participate to the study. In case of a positive answer, the user will receive an electronic questionnaire about its health and medical history and the data recorded from the previous six months on his/her Body Cardio bathroom scale will be collected in the study.
Once consent has been given, the user's data collectedby the WITHINGS Body Cardio scales will be extracted anonymously and associated with the answers to the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Significant PWV difference | – | Other: Percentage analysisPopulation with a significant difference PWV between the right and left lower limbs. |
| No significant PWV difference | – | Other: Percentage analysisPopulation with no significant difference PWV between the right and left lower limbs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Active and regular user of the Withings Body Cardio Bathroom Scale
Key inclusion criteria (4 listed)
- Active and regular user of the device
- Adult participant
- Participant who agreed to participate in the study, after reading the study information letter
- Participant living in France
Key exclusion criteria (1 listed)
- User who didn't agreed to participate to the study after reading the study information letter
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 |
|---|---|---|
| Percentage analysisAnalysis the percentage of the population with risk factors that may lead to a PAD. | Other | No significant PWV difference, Significant PWV difference |
Primary outcome
Analysis of the distribution of risk factors for people with a high People with significant PWV difference will be compared to people with no significant PWV difference
Time frame: 1 year
Chi 2 test between the two population
1 secondary outcome
Acceptability of the device
Time frame: 1 year
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 24 Jul 2025.
- 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.
Pierre Boutouyrie, Pr principal investigator
Georges Pompidou European Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PAD - Peripheral Arterial Disease, run by Withings at 1 site in France.
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 4 inclusion and 1 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 24 Jul 2025. 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 France. 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?
Analysis of the distribution of risk factors for people with a high People with significant PWV difference will be compared to people with no significant PWV difference (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.