Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids

NCT02844920 | Completed Results FDA Device

• 1 other identifier: CL04897
• Study Type: observational
• Target: 37
• Locations: 4 countries
• Sites: 6

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.

Conditions

Uterine Fibroids; Adhesions

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids

  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.

  6 weeks

Secondary Outcomes (1)

• Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated

  6 weeks

Study Arms (1)

Fibroid Treatment

Intrauterine ultrasound guided radio-frequency ablation

Device: Intrauterine ultrasound guided radio-frequency ablation

Interventions

Intrauterine ultrasound guided radio-frequency ablation DEVICE

Radiofrequency ablation for the treatment of uterine fibroids

Also known as: Sonata System

Fibroid Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who desire treatment of intrauterine fibroids with RF ablation via the Sonata System.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynesonics: lead

Study Sites (6)

Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, 68167, Germany

Location

Klinikum Oldenburg

Oldenburg, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Maxima Medisch Centrum (MMC)

Veldhoven, Netherlands

Location

Universitätsklinik für Frauenheilkunde Inselspital Bern

Bern, Switzerland

Location

St. Mary's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Leiomyoma; Tissue Adhesions

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs)
• Organization: Gynesonics

tfarazi@gynesonics.com

650-216-3878

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 26, 2016
• Study Start: July 20, 2017
• Primary Completion: August 27, 2018
• Study Completion: August 27, 2018
• Last Updated: September 20, 2019
• Results First Posted: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); NL (1); CH (1); DE (3)