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A soft pressure-sensitive skin sensor to measure lymphoedema treatment efficiency

Functionalities of Flowpresso® to determine patient-specific treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12712868
Enrollment
10
Registered
2023-09-21
Start date
2023-09-25
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoedema in Maori and Pacific participants Circulatory System

Interventions

The Centre for Health (TCFH) will recruit 10 participants from the Maori or Pacific Community to undertake three FLOWpresso sessions, one per week. Three sessions in previous trials have shown to achi

Sponsors

The Centre for Health (New Zealand)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Of Maori or Pacific ethnicity 2. At least 18 years old 3. Volunteered to participate in this study 4. Volunteered to sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Not of Maori or Pacific ethnicity 2. Under 18 years old 3. Pregnant or breastfeeding 4. Have congested heart failure 5. Have a pacemaker or defibrillator 6 Have a history of blood clots or deep vein thrombosis 7. Lymphoedema

Design outcomes

Primary

MeasureTime frame
1. The amount of compression exerted on the tissue by the FLOWpresso suit, measured using the IDEs sensor at sessions 1-3 2. Lymphoedema in limbs measured using bioimpedance spectroscopy (BIS) before and after each session (1-3) 3. Tissue stiffness measured using a Skin FibroMeter before and after each session (1-3)

Secondary

MeasureTime frame
1. The health and wellbeing of Maori and Pacific participants, measured using a culturally appropriate Kaupapa Maori QOL Questionnaire prior to the first session and after the third session 2. Sleep disturbance measured using DSM-5 Level 2 – Sleep Disturbance Questionnaire prior to session 1 and after session 3

Countries

New Zealand

Contacts

Public ContactTasha Burton
maraea@thecentreforhealth.co.nz+64 (0)7 578 6624

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026