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Sponsored by: |
Elesta S.R.L. |
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Information provided by: | Elesta S.R.L. |
ClinicalTrials.gov Identifier: | NCT00858104 |
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 |
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Thyroid Nodule |
Procedure: Percutaneous Laser Ablation |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 2011 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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.
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2: No Intervention |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia | Recruiting |
Perugia, Italy, 06126 | |
Contact: Pierpaolo De Feo, MD 075-5783673 ext +39 defeo@dimisem.med.unipg.it | |
Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello | Recruiting |
Pisa, Italy, 56124 | |
Contact: Aldo Pinchera, MD 050-544723 ext +39 a.pinchera@endoc.med.unipi.it | |
Arcispedale S. Maria Nuova | Recruiting |
Reggio Emilia, Italy, 42100 | |
Contact: Roberto Valcavi, MD 0522-296630 ext +39 roberto.valcavi@asmn.re.it | |
Italy, ROMA | |
Ospedale Regina Apostolorum | Recruiting |
Albano Laziale, ROMA, Italy, 00041 | |
Contact: Giancarlo Bizzarri, MD 06-93298824 ext +39 bizzarrigiancarlo@libero.it |
Responsible Party: | Elesta SRL ( Serse Pierotti ) |
Study ID Numbers: | IALT-07 |
Study First Received: | March 6, 2009 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00858104 History of Changes |
Health Authority: | Italy: Ethics Committee |
Thyroid Neoplasms Thyroid Nodule Diazepam Head and Neck Neoplasms Anesthetics |
Endocrine System Diseases Endocrinopathy Thyroid Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Thyroid Neoplasms Thyroid Nodule |
Head and Neck Neoplasms Endocrine System Diseases Thyroid Diseases Endocrine Gland Neoplasms |