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Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids (OPEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844920
Recruitment Status : Completed
First Posted : July 26, 2016
Results First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gynesonics

Tracking Information
First Submitted Date July 22, 2016
First Posted Date July 26, 2016
Results First Submitted Date August 12, 2019
Results First Posted Date September 20, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date July 20, 2017
Actual Primary Completion Date August 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2019)
Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids [ Time Frame: 6 weeks ]
Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.
Original Primary Outcome Measures
 (submitted: July 22, 2016)
Presence or absence of intrauterine adhesions following RF ablation of fibroids [ Time Frame: 6 weeks ]
Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following treatment with the Sonata System
Change History
Current Secondary Outcome Measures
 (submitted: September 18, 2019)
Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated [ Time Frame: 6 weeks ]
As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.
Original Secondary Outcome Measures
 (submitted: July 22, 2016)
  • Subject Satisfaction and Overall treatment Effect [ Time Frame: 6 weeks ]
    Participants will complete a questionnaire allowing them to provide their opinion on their satisfaction with the treatment as well as their perception of the effectiveness of the treatment.
  • Return to Normal Daily Activity [ Time Frame: 14 days following procedure ]
    Subjects will be asked to keep a recovery diary to determine their return to normal daily activities. The diary will be kept for 14 days following treatment.
  • Quality of Life questionnaire [ Time Frame: Baseline and 6 weeks following procedure ]
    Subjects will be asked to complete the EuroQOL EQ-5D questionnaire prior to and 6 weeks following treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
Official Title Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
Brief Summary This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.
Detailed Description

Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions.

Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals who desire treatment of intrauterine fibroids with RF ablation via the Sonata System.
Condition
  • Uterine Fibroids
  • Adhesions
Intervention Device: Intrauterine ultrasound guided radio-frequency ablation
Radiofrequency ablation for the treatment of uterine fibroids
Other Name: Sonata System
Study Groups/Cohorts Fibroid Treatment
Intrauterine ultrasound guided radio-frequency ablation
Intervention: Device: Intrauterine ultrasound guided radio-frequency ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 9, 2018)
37
Original Estimated Enrollment
 (submitted: July 22, 2016)
60
Actual Study Completion Date August 27, 2018
Actual Primary Completion Date August 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding
  • Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5)
  • Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements

Exclusion Criteria:

  • Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator
  • One or more Type 0 fibroids and/or endometrial polyps of any size
  • Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Netherlands,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02844920
Other Study ID Numbers CL04897
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: This observational study is intended to view the group as an entirety, individual participant data will be analyzed for adhesions but will not be shared independently.
Responsible Party Gynesonics
Study Sponsor Gynesonics
Collaborators Not Provided
Investigators Not Provided
PRS Account Gynesonics
Verification Date September 2019