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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)

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003382
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Evaluation Institute of Industrial Technology
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Alpinion Medical Systems
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    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

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (D25.9)Leiomyoma of uterus, unspecified 

    symptomatic leiomyoma
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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