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Post market clinical follow-up investigation to evaluate safety and effectiveness of Magic InBra™ breast pump in expressing and collecting milk from lactating women`s breasts

Post market clinical follow-up investigation to evaluate safety and effectiveness of Magic InBra™ breast pump in expressing and collecting milk from lactating women`s breasts - Magic InBra™ (MIB) Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036520
Enrollment
43
Registered
2025-05-05
Start date
2025-06-02
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Pumping milk

Interventions

Group 1: Magic InBra™ breast pump Group 2: Historical data

Sponsors

Medela AG
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Participant > 18 years old 2. Infant is 1 > and < 6 month old 3. Participant and infant are healthy according to self-declaration in the “Mother and infant health questionnaire” 4. Participant is predominantly feeding her own milk (80% of all feeds are participant`s own milk, i.e. < 150ml formula/ day or equal representative amount of solid food) 5. Participant is currently using a breast pump for her infant 6. Participant understand and are willing to follow the study procedures 7. Participant signed the Informed Consent Form

Exclusion criteria

Exclusion criteria: 1. Mastitis (any breast within two weeks prior to enrolment) 2. Engorgement (any breast within two weeks prior to enrolment) 3. Pregnant women 4. Participation in another clinical study during the present Magic InBra™ study or within the last 26 weeks preceding the present study

Design outcomes

Primary

MeasureTime frame
Percentage (%) of available milk removed (PAMR) after 15 minutes of controlled double pumping with the Magic InBra™ breast pumps during the first visit on-site

Secondary

MeasureTime frame
Assessment Adverse Events and Device Deficiency throughout the study

Countries

Switzerland

Contacts

Public ContactMadlen Bach

Medela AG

madlen.bach@medela.com+41415621249

Outcome results

None listed

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