Trial Outcomes & Findings for Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids (NCT NCT02844920)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

37 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Fibroid Treatment Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids
Overall Study STARTED	37
Overall Study Completed Without Evaluable Videos	1
Overall Study Completed With Evaluable Videos	34
Overall Study Completed, Eval. Data, Opposing Fibroids	6
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Fibroid Treatment Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids
Overall Study Lost to Follow-up	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fibroid Treatment n=37 Participants Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids
Age, Continuous	42.4 years STANDARD_DEVIATION 7.17 • n=37 Participants
Sex: Female, Male Female	37 Participants n=37 Participants
Sex: Female, Male Male	0 Participants n=37 Participants
BMI	25.4 kg/m^2 STANDARD_DEVIATION 5.23 • n=37 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Participants with completed follow-up assessment and had evaluable hysteroscopy videos.

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.

Outcome measures

Outcome measures
Measure	Fibroid Treatment n=34 Participants Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids
Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids	34 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants who completed the follow-up assessment, had evaluable hysteroscopy videos, and had 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.

Outcome measures

Outcome measures
Measure	Fibroid Treatment n=6 Participants Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids
Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated	6 Participants

Adverse Events

Fibroid Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fibroid Treatment n=37 participants at risk Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids
Hepatobiliary disorders Gall Stones	2.7% 1/37 • Number of events 1 • 6 weeks

Other adverse events

Adverse event data not reported

Additional Information

Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs)

Gynesonics

Phone: 650-216-3878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60