Skip to main content
MedPathMedPath Home
Clinical Trials/NCT03328260
NCT03328260
Completed
Not Applicable

Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma

Seoul National University Hospital1 site in 1 country34 target enrollmentDecember 12, 2017
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsUterine Leiomyoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uterine Leiomyoma
Sponsor
Seoul National University Hospital
Enrollment
34
Locations
1
Primary Endpoint
Non perfused volume
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma

Registry
clinicaltrials.gov
Start Date
December 12, 2017
End Date
June 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Premenopausal (FSH \< 40 IU/L)
  • •Symptomatic uterine fibroids
  • •Willing to contracept during study period

Exclusion Criteria

  • •Pregnant or willing to be pregnant in future
  • •Cancer in female reproductive organ is suspected or diagnosed
  • •Inflammation in female reproductive organ
  • •Poorly controlled systemic disease
  • •Hematocrit \< 25%
  • •Glomerular filtration rate(GFR) \<= 30ml/min
  • •Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS)
  • •Cannot lie down
  • •Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks
  • •Cannot count the number or measure volume of leiomyoma using MRI

Outcomes

Primary Outcomes

Non perfused volume

Time Frame: treatment day

Non perfused volume in myoma immediately after ablation

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Early Phase 1
High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid NodulesAutonomous Hyperfunctioning Thyroid Nodules
NCT02169687Theraclion2
Completed
Not Applicable
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective CraniotomyCerebrospinal Fluid Leakage
NCT01295619Kuros Biosurgery AG41
Active, not recruiting
Not Applicable
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the PeripheryChronic Venous Insufficiency, CVIVenous MalformationsVenous Leg UlcersKlippel-Trenaunay SyndromeCLOVES SyndromeBlue Rubber Bleb Nevus Syndrome
NCT06642051Sonablate30
Completed
Not Applicable
VALVOSOFT® Pivotal StudyAortic Valve CalcificationAortic Valve Stenosis
NCT05235568Cardiawave SA60
Not yet recruiting
Not Applicable
HIFU Treatment of Benign Thyroid NodulesThyroid Nodule (Benign)
NCT04233398Theraclion240