Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-31 @ 1:02 AM
Study NCT ID:
NCT02246504
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2014-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Sponsor:
Theraclion
Organization:
Study Overview
Official Title:
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: