Trials / Completed
CompletedNCT02491502
Treatment of Benign Thyroid Nodules With FastScan HIFU
Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Theraclion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.
Detailed description
Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area. In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Echopulse | HIFU Under ultrasound guidance |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2020-04-01
- Completion
- 2020-07-01
- First posted
- 2015-07-08
- Last updated
- 2021-10-12
Locations
1 site across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT02491502. Inclusion in this directory is not an endorsement.