Benign Thyroid NodulesNCT02658552
A Prospective Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Benign Thyroid Nodules
A study testing Echopulse in people with Benign Thyroid Nodules, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
To evaluate the short-term efficacy of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Thyroid Nodules
- What is being tested?
- Echopulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient 18 years or older.
- Patient presenting with at least one thyroid nodule with no signs of malignancy:
- Non suspicious clinically and at ultrasonography imaging
- Benign cytological diagnosis at fine needle aspiration biopsy in the last 6 months
- Normal serum calcitonin
- No history of neck irradiation
Show all 12Show fewer
- Serum TSH and free T4 levels within the normal range
- Targeted nodule deemed to be accessible and eligible to HIFU
- Absence of vocal cord paresis at laryngoscopy
- Nodule greatest diameter between ≥10 - 20mm as measured by ultrasound
- Composition of the targeted nodule(s) : predominantly solid
- Patient is mentally competent and has given informed consent.
Who cannot join
- Head and/or neck disease that prevents extension of neck
- Known history of thyroid cancer or other malignant tumors in the neck region
- History of neck irradiation
- Intranodular macrocalcification inducing a shadow in the thyroid significant enough to preclude HIFU treatment
- A nodule next to the posterior margin of the lobe with distance <15mm
- Pregnant or lactating woman
- Any contraindication to the assigned analgesia/anaesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the short-term efficacy of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules
Read the detailed description
Background:
Thyroid nodules are very common worldwide. In an iodine-replete population like Hong Kong, the estimated prevalence of a clinically palpable thyroid nodule, is close to 5% while the prevalence of ultrasonically detectable nodules could be up to 67%. With the frequent use of computed tomography, carotid ultrasound studies and positron emission scans nowadays, many small, non-palpable thyroid nodules are incidentally detected. The use of high intensity focused ultrasound MRI guided or ultrasound guided have been used to treat different types of soft tissue cancer like prostate cancer, liver cancer and breast cancer. This device has been tried in a clinical study where patients with thyroid nodules, who were already scheduled for thyroidectomy, were treated using HIFU in order to evaluate the safety and feasibility of the device and to better determine the treatment parameters and effect.
The results showed that the overall safety of the treatment was satisfactory and the lesions produced by the HIFU shots in the nodule were precise. This pilot study was extended to a clinical trial where patients with a benign thyroid nodule were treated. Twenty-one patients were treated in this study versus 11 controls. No serious adverse events (SAE) have occurred. A patient with a toxic thyroid nodule was also treated with the HIFU device (Theraclion, France). The treatment was well tolerated and biologic euthyroidism was achieved at 3 months (TSH, 1.91 mIU/L) and was maintained at 6, 12, and 18 months. At 12 and 18 months, the treated nodule was barely seen as a nonvascularized hypoechoic scar. Thyroid scintigraphy showed a recovery of the thyroid iodine uptake.
Since November 1st 2007, this HIFU device (Theraclion, France) has been CE marked for HIFU treatment of neck pathologies. 11 patients with primary hyperparathyroidism have been treated and followed. The mean follow-up is 9.5 months (1-28 months).
Symptomatic hypocalcaemia was not observed in any patient after HIFU treatments or during follow-up. A prospective monocenter study was performed in Bulgaria for the treatment of benign solid thyroid nodule by US-Guided HIFU. Twenty thyroid nodules were treated during one HIFU session. The mean ± standard deviation nodule volume was 4.96 mL ± 2.79 at the start of the study. Nodule volume had decreased to 3.05 mL ±1.96 at the 3-month follow-up examination (n = 20, P < .001), and reached 2.91 mL ± 2.43 by the 6-month follow-up examination (n = 16, P < .001). By then, the mean volume reduction was 48.7% ± 24.3 (P< .001). Minor transient complications such as subcutaneous edema and mild skin redness were observed in two patients. Another monocenter study was performed in Germany in 2014. Ten patients with one thyroid nodule each were treated by HIFU. Three months after the procedure, thyroid nodule volume was significantly reduced by 48.8% (median) and a shrinkage up to 75% of the volume was observed. In terms of safety, no serious side effect related to the procedure was reported.
Objectives:
The present study is aimed to explore the followings:
- To evaluate the efficacy of the HIFU for the treatment of benign thyroid nodules using assessment of patient experience and adverse event reporting.
- To evaluate the tolerance of HIFU in the treatment of benign thyroid nodules.
- To determine the location parameters associated with optimal efficiency tissue ablation.
The procedure schedule comprises:
- An first visit (V0)
- The HIFU session (D0)
- A visit at 1, 3 and 7 days after HIFU session (D1, D3, D7)
- A visit at 3 and 6 months (M3, M6).
- At each visit: any local and/or general adverse event will be documented in case report form (CRF).
Ultrasound measurement of the treated nodule (in 3 dimensions) will be performed at each scheduled visit.
The treatment procedure of Echopulse consists of five treatment steps:
- Pre-treatment ultrasonography
- Positioning
- Planning
- Generation of HIFU treatment pulses in the volume defined above; power setting is achieved on regularly spaced sites subsets.
- Post-treatment visualization and final report. The parameters of HIFU treatment will be part of the clinical study data base. When an HIFU session is prematurely interrupted, the reason of interruption will be recorded in the CRF (adverse event, technical failure, others).
Study duration will lbe 6 months for each patient, counting from the post-HIFU day.
- Conditions
- Benign Thyroid Nodules
- Being tested
- Echopulse
- Keywords
- HIFU, Benign thyroid nodule, Low risk, New treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchopulseDevice
Echopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue
| Study group | Role | What they receive |
|---|---|---|
| HIFU treatment | Experimental | To collect the data after HIFU treatment Receives: Device: Echopulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changing volume of benign thyroid nodule after HIFU treatment
Change in volume (ml) of the targeted benign thyroid nodule 6 months after one successful course of HIFU
Measured: 6 months
The changing greatest dimension of benign thyroid nodule after HIFU treatment
Change in greatest dimension (in mm) of the targeted benign thyroid nodule 6 months after one successful course of HIFU
Measured: 6 months
Secondary outcomes (2)
The pain assessment (scoring 1-10) after treatment
Patient pain score immediately after completion of HIFU treatment session.
Measured: 6 months
Incidence of local/ or general adverse events
The incidence rate of local or general adverse events after completion of HIFU treatment session.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Benign Thyroid NodulesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lang Hung Hin, Brian, The University of Hong Kong
- Investigators
- Hung Hin, Brian Lang, MBBS(Hons), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658552
- Sponsor's protocol ID
- UW15-486
- Status last verified
- Sep 2016
- First submitted
- 6 Jan 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hegedus L, Bonnema SJ, Bennedbaek FN. Management of simple nodular goiter: current status and future perspectives. Endocr Rev. 2003 Feb;24(1):102-32. doi: 10.1210/er.2002-0016.
PubMed 12588812Erdogan MF, Gursoy A, Erdogan G. Natural course of benign thyroid nodules in a moderately iodine-deficient area. Clin Endocrinol (Oxf). 2006 Dec;65(6):767-71. doi: 10.1111/j.1365-2265.2006.02664.x.
PubMed 17121528Bergenfelz A, Jansson S, Kristoffersson A, Martensson H, Reihner E, Wallin G, Lausen I. Complications to thyroid surgery: results as reported in a database from a multicenter audit comprising 3,660 patients. Langenbecks Arch Surg. 2008 Sep;393(5):667-73. doi: 10.1007/s00423-008-0366-7. Epub 2008 Jul 17.
PubMed 18633639Sung JY, Baek JH, Kim KS, Lee D, Yoo H, Kim JK, Park SH. Single-session treatment of benign cystic thyroid nodules with ethanol versus radiofrequency ablation: a prospective randomized study. Radiology. 2013 Oct;269(1):293-300. doi: 10.1148/radiol.13122134. Epub 2013 Apr 24.
PubMed 23616630Gharib H, Hegedus L, Pacella CM, Baek JH, Papini E. Clinical review: Nonsurgical, image-guided, minimally invasive therapy for thyroid nodules. J Clin Endocrinol Metab. 2013 Oct;98(10):3949-57. doi: 10.1210/jc.2013-1806. Epub 2013 Aug 16.
PubMed 23956350Baek JH, Lee JH, Valcavi R, Pacella CM, Rhim H, Na DG. Thermal ablation for benign thyroid nodules: radiofrequency and laser. Korean J Radiol. 2011 Sep-Oct;12(5):525-40. doi: 10.3348/kjr.2011.12.5.525. Epub 2011 Aug 24.
PubMed 21927553Zhou YF. High intensity focused ultrasound in clinical tumor ablation. World J Clin Oncol. 2011 Jan 10;2(1):8-27. doi: 10.5306/wjco.v2.i1.8.
PubMed 21603311Kovatcheva RD, Vlahov JD, Shinkov AD, Borissova AM, Hwang JH, Arnaud F, Hegedus L. High-intensity focused ultrasound to treat primary hyperparathyroidism: a feasibility study in four patients. AJR Am J Roentgenol. 2010 Oct;195(4):830-5. doi: 10.2214/AJR.09.3932.
PubMed 20858805Kovatcheva RD, Vlahov JD, Stoinov JI, Kirilov GG, Krivoshiev SG, Arnaud F, Ortuno C, Drueke TB. High-intensity focussed ultrasound (HIFU) treatment in uraemic secondary hyperparathyroidism. Nephrol Dial Transplant. 2012 Jan;27(1):76-80. doi: 10.1093/ndt/gfr590. Epub 2011 Oct 19.
PubMed 22015443Kovatcheva R, Vlahov J, Stoinov J, Lacoste F, Ortuno C, Zaletel K. US-guided high-intensity focused ultrasound as a promising non-invasive method for treatment of primary hyperparathyroidism. Eur Radiol. 2014 Sep;24(9):2052-8. doi: 10.1007/s00330-014-3252-4. Epub 2014 Jun 4.
PubMed 24895038Esnault O, Franc B, Monteil JP, Chapelon JY. High-intensity focused ultrasound for localized thyroid-tissue ablation: preliminary experimental animal study. Thyroid. 2004 Dec;14(12):1072-6. doi: 10.1089/thy.2004.14.1072.
PubMed 15650361Esnault O, Franc B, Chapelon JY. Localized ablation of thyroid tissue by high-intensity focused ultrasound: improvement of noninvasive tissue necrosis methods. Thyroid. 2009 Oct;19(10):1085-91. doi: 10.1089/thy.2009.0121.
PubMed 19803790Esnault O, Franc B, Menegaux F, Rouxel A, De Kerviler E, Bourrier P, Lacoste F, Chapelon JY, Leenhardt L. High-intensity focused ultrasound ablation of thyroid nodules: first human feasibility study. Thyroid. 2011 Sep;21(9):965-73. doi: 10.1089/thy.2011.0141. Epub 2011 Aug 11.
PubMed 21834683Esnault O, Rouxel A, Le Nestour E, Gheron G, Leenhardt L. Minimally invasive ablation of a toxic thyroid nodule by high-intensity focused ultrasound. AJNR Am J Neuroradiol. 2010 Nov;31(10):1967-8. doi: 10.3174/ajnr.A1979. Epub 2010 Jan 14.
PubMed 20075098Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16. doi: 10.1148/radiol.12111300. Epub 2012 Mar 21.
PubMed 22438360
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT02658552
- Acronym / sponsor ID
- UW15-486
- Conditions
- Benign Thyroid Nodules
- Keywords
- HIFU, Benign thyroid nodule, Low risk, New treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the short-term efficacy of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules
Detailed description
Background:
Thyroid nodules are very common worldwide. In an iodine-replete population like Hong Kong, the estimated prevalence of a clinically palpable thyroid nodule, is close to 5% while the prevalence of ultrasonically detectable nodules could be up to 67%. With the frequent use of computed tomography, carotid ultrasound studies and positron emission scans nowadays, many small, non-palpable thyroid nodules are incidentally detected. The use of high intensity focused ultrasound MRI guided or ultrasound guided have been used to treat different types of soft tissue cancer like prostate cancer, liver cancer and breast cancer. This device has been tried in a clinical study where patients with thyroid nodules, who were already scheduled for thyroidectomy, were treated using HIFU in order to evaluate the safety and feasibility of the device and to better determine the treatment parameters and effect.
The results showed that the overall safety of the treatment was satisfactory and the lesions produced by the HIFU shots in the nodule were precise. This pilot study was extended to a clinical trial where patients with a benign thyroid nodule were treated. Twenty-one patients were treated in this study versus 11 controls. No serious adverse events (SAE) have occurred. A patient with a toxic thyroid nodule was also treated with the HIFU device (Theraclion, France). The treatment was well tolerated and biologic euthyroidism was achieved at 3 months (TSH, 1.91 mIU/L) and was maintained at 6, 12, and 18 months. At 12 and 18 months, the treated nodule was barely seen as a nonvascularized hypoechoic scar. Thyroid scintigraphy showed a recovery of the thyroid iodine uptake.
Since November 1st 2007, this HIFU device (Theraclion, France) has been CE marked for HIFU treatment of neck pathologies. 11 patients with primary hyperparathyroidism have been treated and followed. The mean follow-up is 9.5 months (1-28 months).
Symptomatic hypocalcaemia was not observed in any patient after HIFU treatments or during follow-up. A prospective monocenter study was performed in Bulgaria for the treatment of benign solid thyroid nodule by US-Guided HIFU. Twenty thyroid nodules were treated during one HIFU session. The mean ± standard deviation nodule volume was 4.96 mL ± 2.79 at the start of the study. Nodule volume had decreased to 3.05 mL ±1.96 at the 3-month follow-up examination (n = 20, P < .001), and reached 2.91 mL ± 2.43 by the 6-month follow-up examination (n = 16, P < .001). By then, the mean volume reduction was 48.7% ± 24.3 (P< .001). Minor transient complications such as subcutaneous edema and mild skin redness were observed in two patients. Another monocenter study was performed in Germany in 2014. Ten patients with one thyroid nodule each were treated by HIFU. Three months after the procedure, thyroid nodule volume was significantly reduced by 48.8% (median) and a shrinkage up to 75% of the volume was observed. In terms of safety, no serious side effect related to the procedure was reported.
Objectives:
The present study is aimed to explore the followings:
- To evaluate the efficacy of the HIFU for the treatment of benign thyroid nodules using assessment of patient experience and adverse event reporting.
- To evaluate the tolerance of HIFU in the treatment of benign thyroid nodules.
- To determine the location parameters associated with optimal efficiency tissue ablation.
The procedure schedule comprises:
- An first visit (V0)
- The HIFU session (D0)
- A visit at 1, 3 and 7 days after HIFU session (D1, D3, D7)
- A visit at 3 and 6 months (M3, M6).
- At each visit: any local and/or general adverse event will be documented in case report form (CRF).
Ultrasound measurement of the treated nodule (in 3 dimensions) will be performed at each scheduled visit.
The treatment procedure of Echopulse consists of five treatment steps:
- Pre-treatment ultrasonography
- Positioning
- Planning
- Generation of HIFU treatment pulses in the volume defined above; power setting is achieved on regularly spaced sites subsets.
- Post-treatment visualization and final report. The parameters of HIFU treatment will be part of the clinical study data base. When an HIFU session is prematurely interrupted, the reason of interruption will be recorded in the CRF (adverse event, technical failure, others).
Study duration will lbe 6 months for each patient, counting from the post-HIFU day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU treatment | Experimental | Device: EchopulseTo collect the data after HIFU treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patient 18 years or older.
- Patient presenting with at least one thyroid nodule with no signs of malignancy:
- Serum TSH and free T4 levels within the normal range
- Targeted nodule deemed to be accessible and eligible to HIFU
- Absence of vocal cord paresis at laryngoscopy
Key exclusion criteria (7 listed)
- Head and/or neck disease that prevents extension of neck
- Known history of thyroid cancer or other malignant tumors in the neck region
- History of neck irradiation
- Intranodular macrocalcification inducing a shadow in the thyroid significant enough to preclude HIFU treatment
- A nodule next to the posterior margin of the lobe with distance <15mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchopulseEchopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue | Device | HIFU treatment |
Primary outcome
The changing volume of benign thyroid nodule after HIFU treatment
Time frame: 6 months
Change in volume (ml) of the targeted benign thyroid nodule 6 months after one successful course of HIFU
The changing greatest dimension of benign thyroid nodule after HIFU treatment
Time frame: 6 months
Change in greatest dimension (in mm) of the targeted benign thyroid nodule 6 months after one successful course of HIFU
2 secondary outcomes
The pain assessment (scoring 1-10) after treatment
Time frame: 6 months
Incidence of local/ or general adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Background: PubMed 12588812Hegedus L, Bonnema SJ, Bennedbaek FN. Management of simple nodular goiter: current status and future perspectives. Endocr Rev. 2003 Feb;24(1):102-32. doi: 10.1210/er.2002-0016.
- Background: PubMed 17121528Erdogan MF, Gursoy A, Erdogan G. Natural course of benign thyroid nodules in a moderately iodine-deficient area. Clin Endocrinol (Oxf). 2006 Dec;65(6):767-71. doi: 10.1111/j.1365-2265.2006.02664.x.
- Background: PubMed 18633639Bergenfelz A, Jansson S, Kristoffersson A, Martensson H, Reihner E, Wallin G, Lausen I. Complications to thyroid surgery: results as reported in a database from a multicenter audit comprising 3,660 patients. Langenbecks Arch Surg. 2008 Sep;393(5):667-73. doi: 10.1007/s00423-008-0366-7. Epub 2008 Jul 17.
- Background: PubMed 23616630Sung JY, Baek JH, Kim KS, Lee D, Yoo H, Kim JK, Park SH. Single-session treatment of benign cystic thyroid nodules with ethanol versus radiofrequency ablation: a prospective randomized study. Radiology. 2013 Oct;269(1):293-300. doi: 10.1148/radiol.13122134. Epub 2013 Apr 24.
- Background: PubMed 23956350Gharib H, Hegedus L, Pacella CM, Baek JH, Papini E. Clinical review: Nonsurgical, image-guided, minimally invasive therapy for thyroid nodules. J Clin Endocrinol Metab. 2013 Oct;98(10):3949-57. doi: 10.1210/jc.2013-1806. Epub 2013 Aug 16.
- Background: PubMed 21927553Baek JH, Lee JH, Valcavi R, Pacella CM, Rhim H, Na DG. Thermal ablation for benign thyroid nodules: radiofrequency and laser. Korean J Radiol. 2011 Sep-Oct;12(5):525-40. doi: 10.3348/kjr.2011.12.5.525. Epub 2011 Aug 24.
- Background: PubMed 21603311Zhou YF. High intensity focused ultrasound in clinical tumor ablation. World J Clin Oncol. 2011 Jan 10;2(1):8-27. doi: 10.5306/wjco.v2.i1.8.
- Background: PubMed 20858805Kovatcheva RD, Vlahov JD, Shinkov AD, Borissova AM, Hwang JH, Arnaud F, Hegedus L. High-intensity focused ultrasound to treat primary hyperparathyroidism: a feasibility study in four patients. AJR Am J Roentgenol. 2010 Oct;195(4):830-5. doi: 10.2214/AJR.09.3932.
- Background: PubMed 22015443Kovatcheva RD, Vlahov JD, Stoinov JI, Kirilov GG, Krivoshiev SG, Arnaud F, Ortuno C, Drueke TB. High-intensity focussed ultrasound (HIFU) treatment in uraemic secondary hyperparathyroidism. Nephrol Dial Transplant. 2012 Jan;27(1):76-80. doi: 10.1093/ndt/gfr590. Epub 2011 Oct 19.
- Background: PubMed 24895038Kovatcheva R, Vlahov J, Stoinov J, Lacoste F, Ortuno C, Zaletel K. US-guided high-intensity focused ultrasound as a promising non-invasive method for treatment of primary hyperparathyroidism. Eur Radiol. 2014 Sep;24(9):2052-8. doi: 10.1007/s00330-014-3252-4. Epub 2014 Jun 4.
- Background: PubMed 15650361Esnault O, Franc B, Monteil JP, Chapelon JY. High-intensity focused ultrasound for localized thyroid-tissue ablation: preliminary experimental animal study. Thyroid. 2004 Dec;14(12):1072-6. doi: 10.1089/thy.2004.14.1072.
- Background: PubMed 19803790Esnault O, Franc B, Chapelon JY. Localized ablation of thyroid tissue by high-intensity focused ultrasound: improvement of noninvasive tissue necrosis methods. Thyroid. 2009 Oct;19(10):1085-91. doi: 10.1089/thy.2009.0121.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung Hin, Brian Lang, MBBS(Hons) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echopulse in people with Benign Thyroid Nodules, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changing volume of benign thyroid nodule after HIFU treatment (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658552, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.