NCT02246504

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

4.4 years

First QC Date

September 16, 2014

Last Update Submit

September 13, 2019

Conditions

Non-malignant Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in thyroid nodule's volume

    Month 6

Secondary Outcomes (2)

  • Change from baseline in thyroid nodule's structure and vascularisation

    Month 6

  • Number of participants with adverse events

    D1, D7, M1, M3 and M6

Study Arms (1)

HIFU treatment

EXPERIMENTAL

use of HIFU treatment in patients with non-malignant thyroid nodules

Device: HIFU treatment

Interventions

HIFU treatmentDEVICE
HIFU treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient 18 years or older.
  • Patient presenting with at least one thyroid nodule with no signs of malignancy:
  • Non suspect clinically and at ultrasonography imaging
  • Benign cytological diagnosis at FNAB from the last 6 months
  • Normal serum calcitonin
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street

Sofia, 14031, Bulgaria

Location

Study Officials

  • Roussanka Kovatcheva, Prof.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 22, 2014

Study Start

October 9, 2012

Primary Completion

March 7, 2017

Study Completion

March 7, 2017

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

BU(1)