|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Elesta S.R.L. |
|---|---|
| Information provided by (Responsible Party): | Elesta S.R.L. |
| ClinicalTrials.gov Identifier: | NCT00858104 |
Purpose
Thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. The majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term levothyroxine treatment has, however, several well-known side effects and limitations.
During the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects.
Aim of the study:
To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up. Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.
| Condition | Intervention | Phase |
|---|---|---|
|
Thyroid Nodule |
Procedure: Percutaneous Laser Ablation |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Laser thermal ablation
|
Procedure: Percutaneous Laser Ablation
Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.
Other Names:
|
|
No Intervention: 2
Follow-up
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Ospedale Regina Apostolorum | |
| Albano Laziale, Roma, Italy, 00041 | |
| Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia | |
| Perugia, Italy, 06126 | |
| Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello | |
| Pisa, Italy, 56124 | |
| Arcispedale S. Maria Nuova | |
| Reggio Emilia, Italy, 42100 | |
More Information
| Responsible Party: | Elesta S.R.L. |
| ClinicalTrials.gov Identifier: | NCT00858104 History of Changes |
| Other Study ID Numbers: | IALT-07 |
| Study First Received: | March 6, 2009 |
| Last Updated: | September 19, 2011 |
| Health Authority: | Italy: Ethics Committee |
|
Thyroid Diseases Thyroid Nodule Endocrine System Diseases Thyroid Neoplasms |
Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |