Adhesions, Uterine Fibroids
Conditions
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.
Interventions
DEVICEIntrauterine ultrasound guided radio-frequency ablation
Radiofrequency ablation for the treatment of uterine fibroids
Sponsors
Gynesonics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany, Netherlands, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fibroid Treatment Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Fibroid Treatment | — |
|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 7.17 | — |
| BMI | 25.4 kg/m^2 STANDARD_DEVIATION 5.23 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 1 / 37 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: Participants with completed follow-up assessment and had evaluable hysteroscopy videos.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fibroid Treatment | Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids | 34 Participants |
Secondary
Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated
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
Population: Participants who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fibroid Treatment | Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated | 6 Participants |