None listed
Conditions
Interventions
Medical Device : The intervention in this clinical trial is the HCURE histotripsy procedure, a non-invasive ultrasound-based tissue destruction technique. The trial is conducted as a single-arm study
therefore, no differences exist between intervention groups. The procedure targets the participant’s benign thyroid nodule and induces cavitation to mechanically disrupt the nodule tissue. All partici
Sponsors
Alpinion Medical Systems
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following inclusion criteria must all be satisfied for a subject to participate in this clinical trial. 1. Adults aged 19 years or older 2. Subjects who, within 12 months prior to the screening visit, meet all of the following conditions regarding thyroid nodules: ? Confirmed benign at least once by fine needle aspiration biopsy (FNAB) ? Confirmed benign at least once by core needle biopsy (CNB) 3. Subjects who, at the time of screening, present with one or more benign thyroid nodules causing one or more of the following symptoms: ? Compression symptoms due to pressure on surrounding tissues at the procedure site, or cosmetic issues such as protrusion at the procedure site ? Nodules observed to be persistently growing * Increase in nodule diameter of = 2 mm at least at two measurement points and increase in nodule volume of = 20% compared to ultrasound performed within the past 24 months 4. Subjects whose benign thyroid nodules observed on ultrasound at the time of screening meet all of the following conditions: ? Longest diameter of nodule = 2 cm ? Nodule volume = 10 cc ? Solid component = 70% ? Distance from carotid artery = 2 mm ? Distance from trachea = 5 mm ? Distance from skin to maximum depth of nodule = 5 mm and = 60 mm ? Necrotic or calcified portion < 10% of the entire nodule 5. Subjects whose laboratory test results at the time of screening fall within the normal range for all of the following items: ? Thyroid stimulating hormone (TSH) 0.5 mIU/L = TSH = 5.0 mIU/L ? Calcitonin 1.2 ng/L = Calcitonin = 10.9 ng/L ? Platelet (PLT) = 50,000 uL ? Prothrombin time (PT) = 15 sec ? PT activity < 150% ? PT INR = 1.5 ? Activated partial thromboplastin time (aPTT) = 40 sec 6. Subjects who have decided not to undergo surgical excision for benign thyroid nodules (e.g., total thyroidectomy, partial thyroidectomy, etc.) 7. Subjects who voluntarily decide to participate in this clinical trial and provide written informed consent 8. Subjects who are willing to comply with the clinical trial protocol
Exclusion criteria
Exclusion criteria: A subject who meets any of the following exclusion criteria is not eligible to participate in this clinical trial. 1. Subjects with any of the following procedural histories and/or medical histories at the procedure site: ? Prior radiation therapy ? Thyroid cancer ? Diagnosis of other malignant tumors 2. Subjects who, at the time of screening, meet one or more of the following conditions and are considered inappropriate for the application of the investigational medical device: ? Unable to maintain a supine neck hyperextension position ? Presence of scars or tattoos in the area to be scanned by ultrasound ? Presence of surgically implanted devices (e.g., clips) in the ultrasound path that could cause burns 3. Subjects with hypersensitivity to amide-type analgesics 4. Subjects with psychiatric disorders or cognitive impairment that prevent adherence to the clinical trial procedures or effective communication 5. Pregnant or breastfeeding subjects 6. Female subjects of childbearing potential who do not agree to use medically acceptable contraception* during the clinical trial * Medically acceptable contraception includes intrauterine device (IUD) or intrauterine system (IUS), tubal ligation, double barrier methods (e.g., male condom + female condom, cervical cap, diaphragm, contraceptive sponge), or single barrier method combined with spermicides 7. Subjects currently participating in another clinical trial or who have participated in another clinical trial within 90 days prior to the screening visit 8. Other cases where the investigator considers the subject ethically or clinically inappropriate for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nodule volume change (cc) and percentage change (%) at each visit relative to baseline;Ablated tissue volume (cc);Residual nodule volume (cc);Tissue blood flow assessment at each visit;Procedure-related pain assessment (score);Change in pressure symptom score at treatment site (points) relative to baseline (visit 3, 4);Cosmetic outcome at treatment site (baseline and visit 3, 4);Adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactSOO YEON KANG
Seoul National University Hospital
Outcome results
None listed