Patients with cardiac implantable electrical devices Cardiac implantable electrical devices (CIEDs) Cardiac permanent pacemakers (PPM) Implantable cardioverter defibrillators (ICDs) Electromagnetic interference (EMI) Micro and Macro Focused Ultrasound (MMFU) Skin tightening
Conditions
Interventions
Micro- and Macro-Focused Ultrasound (MMFU) is a non-invasive, energy-based technology used for skin tightening and lifting. MMFU delivers ultrasound energy to precise depths within the skin through fo
Experimental Procedure/Surgery
Micro and Macro Focused Ultrasound: MMFU
Sponsors
Naresuan University Hospital
ABCA PHARMA LAB (THAILAND) CO.,LTD.
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 30 years or older and able to read and write. 2. Have mild to moderate skin laxity or wrinkles and are interested in undergoing facial tightening procedures. 3. Have had a cardiac implantable electronic device (CIED) in place for at least 3 months, with normal device function confirmed by their cardiologist during routine outpatient follow-up, including documentation of normal CIED parameters such as battery status, sensing, threshold, and impedance. 4. Have a well-controlled cardiovascular condition, as assessed by their cardiologist, including the absence of dyspnea or orthopnea, chest pain, edema, clinically significant tachyarrhythmia requiring intravenous medication, abnormal blood pressure, or clinical signs of heart failure. 5. Their primary cardiologist approves and consents to their participation in the study.
Exclusion criteria
Exclusion criteria: 1. Abnormal functioning of the participant's cardiac implantable electronic device (CIED). 2. Poorly controlled cardiovascular disease, as assessed by the participant's cardiologist during routine follow-up. 3. Presence of open wounds on the face or neck, or severe inflammatory acne/cystic acne in the treatment area. 4. Presence of metallic wires, bio-absorbable implants, or dental implants in the facial or neck areas targeted for treatment. 5. Current pregnancy or breastfeeding. 6. Presence of keloid scars in the treatment area. 7. Active infectious diseases or other active dermatologic conditions that may increase the risk of infection spreading. 8. Impaired wound-healing ability, such as current use of immunosuppressive medications. 9. Determination by the participant's cardiologist that the individual is unsuitable for participation, including dyspnea or orthopnea, chest pain, edema, significant tachyarrhythmia requiring intravenous medication, current hospitalization for cardiovascular disease, wtih any of the above cardiac symptoms occurring within the past month. 10. CIED function deemed medically inappropriate for study participation based on pre-procedure device assessment, including any of the following findings: Battery nearing depletion (e.g., ERI or EOL status), Abnormally high or low impedance (e.g., >2,000 ohms or <200 ohms), Pacing threshold increased to at least twice the previous baseline value.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electromagnetic interference (EMI) at operating frequencies of 2, 4, 5.5, and 7 MHz peri-/post procedural (immediate, and every day for 7 days)) Physician and patient reported | — |
Secondary
| Measure | Time frame |
|---|---|
| Electromagnetic interference (EMI) at different energy levels and various energy-delivery patterns peri-/post procedural (immediate, and every day for 7 days)) Physician and patient reported | — |
Countries
Thailand
Contacts
Public ContactNitina Yeesibsean
Naresuan University Hospital
Outcome results
None listed