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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

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.

Condition or disease Intervention/treatment
Uterine Fibroids Adhesions Device: Intrauterine ultrasound guided radio-frequency ablation

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.


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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions Ultrasound

Group/Cohort Intervention/treatment
Fibroid Treatment
Intrauterine ultrasound guided radio-frequency ablation
Device: Intrauterine ultrasound guided radio-frequency ablation
Radiofrequency ablation for the treatment of uterine fibroids
Other Name: Sonata System




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who desire treatment of intrauterine fibroids with RF ablation via the Sonata System.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844920


Locations
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Germany
Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, Germany, 68167
Klinikum Oldenburg
Oldenburg, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Netherlands
Maxima Medisch Centrum (MMC)
Veldhoven, Netherlands
Switzerland
Universitätsklinik für Frauenheilkunde Inselspital Bern
Bern, Switzerland
United Kingdom
St. Mary's Hospital
London, United Kingdom
Sponsors and Collaborators
Gynesonics
  Study Documents (Full-Text)

Documents provided by Gynesonics:
Study Protocol  [PDF] May 1, 2017
Statistical Analysis Plan  [PDF] October 16, 2018


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Responsible Party: Gynesonics
ClinicalTrials.gov Identifier: NCT02844920     History of Changes
Other Study ID Numbers: CL04897
First Posted: July 26, 2016    Key Record Dates
Results First Posted: September 20, 2019
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (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.

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases