OPEN: Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids [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
- Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg | Mannheim | Germany | 68167 | |
| 2 | Klinikum Oldenburg | Oldenburg | Germany | ||
| 3 | Universitätsklinikum Tübingen | Tübingen | Germany | ||
| 4 | Maxima Medisch Centrum (MMC) | Veldhoven | Netherlands | ||
| 5 | Universitätsklinik für Frauenheilkunde Inselspital Bern | Bern | Switzerland | ||
| 6 | St. Mary's Hospital | London | United Kingdom |
Sponsors and Collaborators
- Gynesonics
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- CL04897
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Fibroid Treatment |
|---|---|
| Arm/Group Description | Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids |
| Period Title: Overall Study | |
| STARTED | 37 |
| Completed Without Evaluable Videos | 1 |
| Completed With Evaluable Videos | 34 |
| Completed, Eval. Data, Opposing Fibroids | 6 |
| COMPLETED | 35 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Fibroid Treatment |
|---|---|
| Arm/Group Description | Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids |
| Overall Participants | 37 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
42.4
(7.17)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
37
100%
|
| Male |
0
0%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| BMI (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
25.4
(5.23)
|
Outcome Measures
| Title | Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids |
|---|---|
| Description | 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. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with completed follow-up assessment and had evaluable hysteroscopy videos. |
| Arm/Group Title | Fibroid Treatment |
|---|---|
| Arm/Group Description | Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids |
| Measure Participants | 34 |
| Count of Participants [Participants] |
34
91.9%
|
| Title | Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated |
|---|---|
| Description | 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. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated. |
| Arm/Group Title | Fibroid Treatment |
|---|---|
| Arm/Group Description | Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids |
| Measure Participants | 6 |
| Count of Participants [Participants] |
6
16.2%
|
Adverse Events
| Time Frame | 6 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Fibroid Treatment | |
| Arm/Group Description | Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids | |
All Cause Mortality |
||
| Fibroid Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | |
Serious Adverse Events |
||
| Fibroid Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/37 (2.7%) | |
| Hepatobiliary disorders | ||
| Gall Stones | 1/37 (2.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Fibroid Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs) |
|---|---|
| Organization | Gynesonics |
| Phone | 650-216-3878 |
| tfarazi@gynesonics.com |
- CL04897