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Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118037
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Gynesonics

Study Description
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Brief Summary:
SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.

Condition or disease Intervention/treatment
Uterine Fibroid Device: Sonata System

Detailed Description:

Patients whom have selected the CE-marked Sonata system for treatment of fibroids will be approached for study participation. Participation in the trial will consist of data collection in the form of questionnaires prior to and after the treatment at the following intervals: pre-procedure, 4 weeks, 1, 2, 3, 4 and 5 years following treatment.

The following data points will be collected: Length of stay, time to return to normal activities (Treatment Recovery Questionnaire), time to return to sexual activity (Treatment Recovery Questionnaire), change in fibroid symptom severity and quality of life (UFS-QOL), change in general health outcome (EQ-5D), work productivity and activity impairment (WPAI), subject satisfaction and overall treatment effect (Overall Treatment Effect and Satisfaction Questionnaire), pregnancy occurrence and outcome, non-medical re-intervention, adverse events related to the device/procedure.

Validated questionnaires are used where appropriate (UFS-QOL, E1-5D and WPAI). Double data entry will occur to ensure accurate capture of subject reported data. Monitoring will occur throughout the course of the trial to ensure adherence to the protocol.

As an observational trial, there are no pre-specified statistically powered endpoints.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Zaleplon

Groups and Cohorts
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Group/Cohort Intervention/treatment
Sonata
Women who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids
 Device: Sonata System
Transcervical access for radiofrequency ablation of uterine fibroids
Other Name: Transcervical RF Ablation


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Pregnancy and Pregnancy Outcomes [ Time Frame: Up to 5 years-post procedure ]
    Number of subjects with pregnancy and the number of pregnancies during the 5 year follow-up period. Outcome of each pregnancy including pregnancy outcomes, delivery route, antenatal and perinatal complications.

  2. Surgical Re-intervention for Heavy Menstrual Bleeding [ Time Frame: Up to 5 years-post procedure ]
    Number of subjects who had surgical re-intervention to treat heavy menstrual bleeding during the 5 year follow-up period.


Other Outcome Measures:
  1. Uterine Fibroid Symptom - Quality of Life [ Time Frame: Pre-procedure and up to 5 years ]
    UFS-QoL, validated fibroid specific assessment tool

  2. Length of Stay [ Time Frame: From admission to hospital discharge, up to four weeks. ]
    Length of stay (in hours) for the treatment of fibroids with the Sonata System (which occurs at enrollment into the registry).

  3. Time to Return to Normal Daily Activity [ Time Frame: First two weeks post procedure ]
    Questionnaire

  4. Time to Return to Sexual Activity [ Time Frame: First two weeks post procedure ]
    Questionnaire

  5. Change in General Health Outcome [ Time Frame: Pre-procedure and up to 5 years ]
    EQ-5D standardized instrument for use as a measure of health outcome

  6. Work Productivity and Activity Impairment [ Time Frame: Pre-procedure and up to 5 years ]
    Standardized instrument for assessing activity/productivity impairment, commonly used in health economics outcomes research. The tool measure impairment in percentage.

  7. Subject Satisfaction [ Time Frame: At 1 year post procedure and up to 5 years ]
    Questionnaire

  8. Overall Treatment Effect [ Time Frame: At 1 year post procedure and up to 5 years ]
    Questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women with diagnosed uterine fibroids are eligible to participate
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who select to have their uterine fibroids treated with the Sonata System
Criteria

Inclusion Criteria:

  • Have selected Sonata for treatment of symptomatic uterine fibroids or is participating in the OPEN study (Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids, NCT02844920, protocol # CL04897) or has completed participation in the OPEN study within the last 14 months
  • Speaks and reads a language for which questionnaires are available
  • Are greater than or equal to 18 years of age at the time of enrollment
  • Willing and able to read, understand and sign the informed consent form, to participate in the registry and to adhere to all registry study follow-up requirements

Exclusion Criteria:

  • Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in the registry
Contacts and Locations
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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): NCT03118037


Contacts
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Contact: Taraneh G Farazi, PhD 6502163878 tfarazi@gynesonics.com
Contact: Tammy L Morton, MS 6502163868 tmorton@gynesonics.com

Locations
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Germany
Frauenklinik Universitätsklinikum Jena Recruiting
Jena, Germany, 07743
Contact: Ingo Runnebaum, MD         
"Klinikverbund Kempten-Oberallgäu gGmbH" Recruiting
Kempten, Germany, 87439
Contact: Ricardo Felberbaum, MD         
Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH Recruiting
Köln, Germany, 50931
Contact: Thomas Römer, MD         
MarienKrankenhaus Schwerte Frauenklinik Recruiting
Schwerte, Germany, 58239
Contact: Michael Hartmann, MD         
Josephs-Hospital Warendorf Recruiting
Warendorf, Germany, 48231
Contact: Matthias Engelhardt, MD         
Marien Hospital Witten Recruiting
Witten, Germany, 58452
Contact: Sven Schiermeier, MD         
Sponsors and Collaborators
Gynesonics
More Information
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Additional Information:

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Responsible Party: Gynesonics
ClinicalTrials.gov Identifier: NCT03118037    
Other Study ID Numbers: CL 04878
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Gynesonics:
Radiofrequency Ablation
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
Zaleplon
 Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action