NCT02246504

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Theraclion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-malignant Thyroid Nodule

Interventions

Type	Name	Description
DEVICE	HIFU treatment

Timeline

• Start date: 2012-10-09
• Primary completion: 2017-03-07
• Completion: 2017-03-07
• First posted: 2014-09-22
• Last updated: 2019-09-17

Locations

1 site across 1 country: Bulgaria