A Clinical Study to Evaluate the Safety and Performance of PCA Systems (B-Flow, Juvenui Co., Ltd) in Post-Surgical Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011113

Enrollment

Registered

2025-11-07

Start date

2025-11-01

Completion date

Unknown

Last updated

2025-11-17

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 : This clinical trial is a study to evaluate the safety and efficacy of a newly developed patient-controlled analgesia (PCA) pump (B-Flow) compared to an existing approved PCA pump (Acc

there are no differences in the type, amount, timing, or route of administration of the drug infused by the pump. 1. Prepare the test equipment (B-Flow) and control equipment (Accumate1200) according

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients scheduled to undergo routine laparoscopic gastrectomy or colectomy at Asan Medical Center 2. Adult patients aged 20 years or older and under 70 years 3. Patients with an American Society of Anesthesiologists Physical Status (ASA PS) classification of 1 or 2 4. Patients receiving pain management via intravenous patient-controlled analgesia (IV-PCA) following general anesthesia surgery 5. Patients who have voluntarily provided written consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: Exclude patients meeting any of the following criteria: 1. Adult patients under 20 years of age or over 70 years of age 2. Body weight = 50 kg 3. ASA PS = 3 4. Patients with a history of hypersensitivity to fentanyl 5. Cases where preoperative cognitive impairment and communication limitations are judged to make IV-PCA use and pain assessment difficult 6. Patients expected to be unable to provide appropriate responses to questionnaires due to postoperative confusion, neurological abnormalities, ICU admission, etc. 7. Other patients deemed unsuitable by the investigator

Design outcomes

Primary

Measure	Time frame
Backflow Test;Siphon Effect Test;Locking Time Function Test;Single-dose injection timing accuracy;Total infusion volume accuracy;Postoperative nausea and vomiting assessment;Pain occurrence assessment;Delivery to attempt percent (D/A%) assessment	—

Secondary

Measure	Time frame
Equipment Malfunction;Equipment Satisfaction	—

Countries

Korea, Republic of

Contacts

Public ContactJung min Lee

Asan Medical Center

jminyi19@gmail.com+82-2-3010-3878

Outcome results