Comparative Study of IV Pump in Healthy Volunteer

A Randomized, Open-label, Comparative study to assess Accuracy and Safety of IV pump, ®Anyfusion V-100 in Healthy Volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003977

Enrollment

Registered

2019-05-23

Start date

2017-08-28

Completion date

Unknown

Last updated

2019-06-17

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

Conditions

None listed

Interventions

Medical Device : Investigational device : Anyfusion V-100(Meinntech) Comparator : Infusion pump

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age in range 19 - 45 years old 2) Agree to follow the instruction and sign up with Informed Consent Form

Exclusion criteria

Exclusion criteria: 1) Participant in another study within 3 months 2) Patient who have clinically significant disease or history of hepatobiliary disorders, Renal and urinary disorders, nervous system disorders, respiratory disorders, blood and lymphatic system disorders, endocrine disorders, cardiac disorders and psychiatric disorders. 3) Blood pressure SBP = 150mmHg or =100mmHg, DBP = 95mmHg or = 60mmHg in Screening visit 4) Patient who donated blood within 8 weeks or donated apheresis within 4 weeks 5) Estimated Glomerular Filtration Rate, eGFR (by Modification of Diet in Renal Disease, MDRD) < 90 mL/min/1.73 m2 6) Abnormal laboratory values (clinical significant) 7) Patient who will not suitable for the study judged by investigator

Design outcomes

Primary

Measure	Time frame
A volume ratio between actual injection volume and anticipated injection	—

Secondary

Measure	Time frame
Occurance of error	—

Countries

Korea, Republic of

Contacts

Public ContactChang Hyu Choi

Gachon University Gil Medical Center

cch624@gmail.com+82-32-460-3669

Outcome results