Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2014-07-31
2015-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
Echopulse
Interventions
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Echopulse
Eligibility Criteria
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Inclusion Criteria
* 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 fine-needle aspiration biopsy (FNAB) from the last 6 months
3. Normal serum calcitonin
4. No history of neck irradiation
* Normal thyroid-stimulating hormone (TSH).
* Targeted nodule accessible and eligible to HIFU
* Absence of abnormal vocal cord mobility at laryngoscopy.
* Nodule diameter ≥ 10mm measured by ultrasound.
* Nodule volume inferior to 10 cc
* Composition of the targeted nodule(s) : no more than 30% cystic
Exclusion Criteria
* 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 the assigned analgesia/anaesthesia.
18 Years
ALL
No
Sponsors
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Theraclion
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Frasoldati, Dr
Role: PRINCIPAL_INVESTIGATOR
Locations
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Istituto in tecnologie avanzate e modelli assistenziali in oncologia
Reggio Emilia, , Italy
Countries
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Other Identifiers
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HIFU/REG/NT
Identifier Type: -
Identifier Source: org_study_id
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