Trial Outcomes & Findings for Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata (NCT NCT00731341)

Results Overview

Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

up to 4 weeks post procedure.

Results posted on

2021-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Cryoablation for the Treatment of Uterine Fibroids All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryoablation for the Treatment of Uterine Fibroids n=3 Participants All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	46.3 years STANDARD_DEVIATION 1 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment Netherlands	3 participants n=99 Participants

PRIMARY outcome

Timeframe: up to 4 weeks post procedure.

Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)

Outcome measures

Outcome measures
Measure	Cryoablation for the Treatment of Uterine Fibroids n=3 Participants All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Number of Adverse Events	1 Participants

SECONDARY outcome

Timeframe: Prior to hospital discharge (less than 24 hours post-procedure)

Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient

Outcome measures

Outcome measures
Measure	Cryoablation for the Treatment of Uterine Fibroids n=3 Participants All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient	1.86 Units on a scale from 1 to 10 Interval 0.0 to 3.6

SECONDARY outcome

Timeframe: 4 weeks post procedure

The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.

Outcome measures

Outcome measures
Measure	Cryoablation for the Treatment of Uterine Fibroids n=3 Participants All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Time (in Days) to Return to Normal Activity	6 Days Interval 1.0 to 14.0

SECONDARY outcome

Timeframe: Post procedure

Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.

Outcome measures

Outcome measures
Measure	Cryoablation for the Treatment of Uterine Fibroids n=3 Participants All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Number of Participants Discharged on Day of Cryoablation Procedure.	3 Participants

SECONDARY outcome

Timeframe: Post procedure

Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids

Outcome measures

Outcome measures
Measure	Cryoablation for the Treatment of Uterine Fibroids n=3 Participants All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Evaluation of Length of an Average Cryoablation Procedure	65.3 Minutes Interval 51.0 to 74.0

SECONDARY outcome

Timeframe: Post procedure

Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).

Outcome measures

Outcome measures
Measure	Cryoablation for the Treatment of Uterine Fibroids n=3 Participants All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure	4.3 Score from 1 to 5 Interval 4.0 to 5.0

Adverse Events

Cryoablation for the Treatment of Uterine Fibroids

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cryoablation for the Treatment of Uterine Fibroids n=3 participants at risk All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Reproductive system and breast disorders Burning sensation in lower abdomen	33.3% 1/3 • Number of events 1 • up to 4 weeks post-procedure

Additional Information

Joy Benson, CRA

Galil Medical

Phone: 651-287-5112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place