Clinical study on the quality evaluation and performance improvement of the domestic surgical ultrasonic energy device (Disealor)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012085

Enrollment

192

Registered

2026-06-07

Start date

2020-12-16

Completion date

Unknown

Last updated

2026-06-08

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 : 1) 1st year, to evaluate efficacy and safety of domestic ultrasonic energy device Disealor against the Bovie in axillary lymph node dissection. (1) Efficacy: The coagulation and seali

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Breast cancer patients aged between 20-75 years old in whom are diagnosed with breast cancer and receiving breast conserving surgery with or without neoadjuvant chemotherapy. 2) Breast cancer patients receiving axillary lymph node dissection with or without sentinel lymph node biopsy via separate incision. 3) ECOG score of 0-2 4) Patient who agreed to an informed consent, or whose legal representative agreed to an informed consent

Exclusion criteria

Exclusion criteria: 1) Patient who received axillary lymph node dissection previously. 2) Patient who received axillary radiotherapy previously. 3) Patient who is judged to be not eligible for enrollment by clinician.

Design outcomes

Primary

Measure	Time frame
axillary drainage (cc)	—

Secondary

Measure	Time frame
pain of axilllary area and upper arm;numbness of axilllary area and upper arm;ROM of shoulder	—

Countries

Korea, Republic of

Contacts

Public ContactTae Hyun Kim

Inje University Busan Paik Hospital

kitah@hanmail.net+82-51-890-6345

Outcome results