Status Approved
First Submitted Date
2018/11/09
Registered Date
2018/12/07
Last Updated Date
2019/11/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003382 |
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Unique Protocol ID | D-1306-117-500 |
Public/Brief Title | A prospective study to evaluate the safety and efficacy of 'ALPIUS'(high intensity focused ultrasound) in patients with uterine leiomyoma |
Scientific Title | A prospective, single-center, single-group clinical trial to evaluate the safety and efficacy of 'ALPIUS' (US-guided HIFU System, ultrasound-guided high-intensity focused ultrasound) |
Acronym | APM-01 |
MFDS Regulated Study | Yes |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | D-1306-117-500 |
Approval Date | 2013-08-28 |
Institutional Review Board Name | Seoul National University Hospital Medical Device Institutional Review Board |
Institutional Review Board Address | Seoul, Korea 110-744 Seoul, Korea Jongno-gu 101 (Yeongeon-dong 28, Seoul) |
Institutional Review Board Telephone | 02-2072-0694 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jae Young Lee |
Title | Professor |
Telephone | +82-2-2072-3073 |
Affiliation | Seoul National University Hospital |
Address | 101, DAEHAK-RO JONGNO-GU, SEOUL 03080, Rep. of KOREA |
Contact Person for Public Queries | |
Name | Soo Yeon Kang |
Title | CRC |
Telephone | +82-2-2072-3073 |
Affiliation | Seoul National University Hospital |
Address | 101, DAEHAK-RO JONGNO-GU, SEOUL 03080, Rep. of KOREA |
Contact Person for Updating Information | |
Name | Soo Yeon Kang |
Title | CRC |
Telephone | +82-2-2072-3073 |
Affiliation | Seoul National University Hospital |
Address | 101, DAEHAK-RO JONGNO-GU, SEOUL 03080, Rep. of KOREA |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2013-11-07 Actual | |
Target Number of Participant | 29 | |
Primary Completion Date | 2014-10-07 , Actual | |
Study Completion Date | 2014-10-07 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Seoul National University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2013-11-07 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Korea Evaluation Institute of Industrial Technology |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Alpinion Medical Systems |
Organization Type | Others |
7. Study Summary
Lay Summary | To check for validity and safety of the 'ALPIUS (US-guided HIFU System)', an ultrasound-guided, high-intensity-focusing ultrasound operating system developed in Korea at uterine leiomyoma. Prospective, single-center, single-arm clinical trial that will be conducted for a maximum of 29 subjects. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | Medical Device, /Procedure/Surgery |
Intervention Description | One-time HIFU procedure |
Number of Arms | 1 |
Arm 1 |
Arm Label Subjects with symptomatic uterine fibroids |
Target Number of Participant 29 |
|
Arm Type Experimental |
|
Arm Description One-time High-Intensity Focused Ultrasound(HIFU) treatment, No general Anesthesia, |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (D25.9)Leiomyoma of uterus, unspecified symptomatic leiomyoma |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 20Year~No Limit |
|
Description 1. Adult women over 20 years old 2. Premenopausal or postmenopausal (FSH <40mIU / ml) 3. In case the clinician determines that the uterus size is less than 24 weeks of single pregnancy 4. If myoma is diagnosed by MR or US imaging 5. If myoma size is more than 3cm and less than 12cm 6. Unless HIFU has received other treatment for uterine fibroids 7. Treatment If the guidelines for selection of uterine myoma are met 8. Willing to voluntarily agree to the clinical trial and willing to follow the protocol |
|
Exclusion Criteria |
1. Other pelvic disorders such as other tumors, endometriosis, ovarian tumors, acute pelvic disease 2. If you are pregnant or you are pregnant 3. Severe systemic disease 4. Less than 25% hematocrit 5. If the extensive scarring along the anterior abdominal wall exceeds 50% of the area 6. High intensity focused ultrasound passes through scar, surgical clip 7. MRI taboo (including closure phobia) 8. MRI contrast agents taboo 9. If the number or volume of uterine myomas can not be measured by MRI 10. If the glomerular filtration rate (GFR) is less than 30 ml / min 11. When communication is difficult 12. Can not lie down comfortably 13. Patients who have participated in other clinical trials within the past month 14. Hypervascular myoma 15. In addition, if it is judged by the researcher that participation in this trial is inappropriate |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Successful ablation rate of uterine myoma |
|
Timepoint | immediately after procedure |
|
Secondary Outcome(s) 1 | ||
Outcome | pain |
|
Timepoint | 1 month & 3 months after the HIFU |
|
Secondary Outcome(s) 2 | ||
Outcome | Quality of life |
|
Timepoint | 1 month & 3 months after the HIFU |
|
Secondary Outcome(s) 3 | ||
Outcome | Re-intervention rate |
|
Timepoint | immediately after procedure |
|
Secondary Outcome(s) 4 | ||
Outcome | ablated volume shrinkage rate |
|
Timepoint | 1 month & 3 months after the HIFU |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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