Trial Outcomes & Findings for High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma (NCT NCT01291498)

Results Overview

Calcium in the blood is measured from venepuncture

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

12 months post-treatment

Results posted on

2017-12-18

Participant Flow

One patient entered the study. Screening and informed consent was conducted on 19 April 2011 and treatment was conducted at the Churchill Hospital on 31 May 2011

The company manufacturing the device reviewed patient's images before confirming eligibility for treatment.

Participant milestones

Participant milestones
Measure	HIFU Treatment This is a single arm study, all subjects are planned to receive HIFU treatment
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIFU Treatment n=1 Participants This is a single arm study, all subjects are planned to received HIFU treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-treatment

Population: The primary endpoint was not analysed because only one subject was entered and this subject was withdrawn from the study before 12 months after treatment.

Calcium in the blood is measured from venepuncture

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six weeks post-treatment.Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.

Population: Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.

Ca in plasma

Outcome measures

Outcome measures
Measure	HIFU Treatment n=1 Participants This is a single arm study, all subjects are planned to receive HIFU treatment
Eucalcaemia	1 mmol/L

SECONDARY outcome

Timeframe: Up to one year post-treatment

Voice Handicap Index. 30 questions rated on a five point scale from 'never' to 'always' and an overall score from 1 'normal' to 10 'severely impaired'

Outcome measures

Outcome measures
Measure	HIFU Treatment n=1 Participants This is a single arm study, all subjects are planned to receive HIFU treatment
Voice Morbidity	1 units on a scale

Adverse Events

HIFU Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr Radu Mihai

Oxford University Hospitals NHS Trust

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place