Registry - Use of a High Intensity Focused Ultrasound (HI... | NCT02246504

Studies
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.

NCT02246504

Sponsor

Theraclion

Status

Completed

Last Update Posted

Sep 17, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Non-malignant Thyroid Nodule

Interventions

HIFU treatment

Countries

Bulgaria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 9, 2012Actual

Primary Completion Date

Mar 7, 2017Actual

Completion Date

Mar 7, 2017Actual

First Submitted Date

Sep 16, 2014

First Submission Date that Met QC Criteria

Sep 19, 2014

First Posted Date

Sep 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2019

Last Update Posted Date

Sep 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography

Detailed Description

HIFU treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist.

A maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to retreat the patient will be taken at 1 month post-HIFU or later.

Follow-up after HIFU treatment

D1 after HIFU session:

Indirect laryngoscopy to check vocal cord mobility.

D7 after HIFU session

Clinical examination (skin, local symptoms, oedema, voice….),
Ultrasonography and Power Doppler,

M1 after HIFU session

Clinical examination (skin, local symptoms, oedema, voice….),
Ultrasonography and Power Doppler,

M3 after HIFU session

Clinical examination (skin, local symptoms, oedema, voice….),
Ultrasonography and Power Doppler Decision for an additional HIFU course to improve volume reduction.

In case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will be performed

M6 after last HIFU session

Clinical examination (skin, local symptoms, oedema, voice….),
Ultrasonography and Power Doppler
TSH
Free T4
Antithyroid peroxidase antibodies
Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)

M9 after HIFU session

Clinical examination (skin, local symptoms, oedema, voice….),
Ultrasonography and Power Doppler

M12 after last HIFU session

Clinical examination (skin, local symptoms, oedema, voice….),
Ultrasonography and Power Doppler
TSH
Free T4
Antithyroid peroxidase antibodies
Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)

M18, M24, M36 after HIFU session

Clinical examination (skin, local symptoms, oedema, voice….),
Ultrasonography and Power Doppler

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
HIFU treatment	Experimental	use of HIFU treatment in patients with non-malignant thyroid nodules	Device: HIFU treatment

Name	Type	Description	Arm Group Labels	Other Names
HIFU treatment	Device		HIFU treatment

Measure	Description	Time Frame
Change from baseline in thyroid nodule's volume		Month 6

Measure	Description	Time Frame
Change from baseline in thyroid nodule's structure and vascularisation		Month 6
Number of participants with adverse events		D1, D7, M1, M3 and M6

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patient 18 years or older.
Patient presenting with at least one thyroid nodule with no signs of malignancy:
1. Non suspect clinically and at ultrasonography imaging
2. Benign cytological diagnosis at FNAB from the last 6 months
3. Normal serum calcitonin
4. No history of neck irradiation
Normal TSH.
Targeted nodule accessible and eligible to HIFU
Absence of abnormal vocal cord mobility at laryngoscopy.
Nodule diameter ≥ 10mm measured by ultrasound.
Composition of the targeted nodule(s) : no more than 30% cystic

Exclusion Criteria:

Head and/or neck disease that prevents hyperextension of neck.
Known history of thyroid cancer or other neoplasias in the neck region.
History of neck irradiation.
Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
Posterior position of the nodule if the thickness of the nodule is <15mm
Pregnant or lactating woman
Any contraindication to IV neurolept analgesia.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided