Trial Outcomes & Findings for ExAblate Treatment of Uterine Fibroids for Fertility Enhancement (NCT NCT00730886)

NCT ID: NCT00730886

Last Updated: 2018-08-15

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Between the 3 and 9-month post-treatment visits

Results posted on

2018-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	ExAblate Treatment: All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.	Myomectomy Treatment: All patients who had more than 15 grams of fibroid tissue excised.
Overall Study STARTED	2	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	ExAblate Treatment: All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.	Myomectomy Treatment: All patients who had more than 15 grams of fibroid tissue excised.
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

ExAblate Treatment of Uterine Fibroids for Fertility Enhancement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ExAblate Treatment: n=2 Participants All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.	Myomectomy Treatment: All patients who had more than 15 grams of fibroid tissue excised.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Between the 3 and 9-month post-treatment visits

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Between the 3 and 15-month post-treatment visits

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Between the 3 and 15-month post-treatment visits

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Between the 3 and 15-month post-treatment visits

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-treatment

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-treatment

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-treatment

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-treatment

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-treatment

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-treatment

Population: enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Outcome measures

Outcome data not reported

Adverse Events

ExAblate Treatment:

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Myomectomy Treatment:

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ExAblate Treatment: n=2 participants at risk All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.	Myomectomy Treatment: All patients who had more than 15 grams of fibroid tissue excised.
Pregnancy, puerperium and perinatal conditions perinatal fever	50.0% 1/2 • Number of events 1	— 0/0

Other adverse events

Other adverse events
Measure	ExAblate Treatment: n=2 participants at risk All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.	Myomectomy Treatment: All patients who had more than 15 grams of fibroid tissue excised.
Skin and subcutaneous tissue disorders blood tinged mucus peri-rectum	50.0% 1/2 • Number of events 1	— 0/0

Additional Information

Nadir Alikacem

InSightec

Phone: 214-630-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place