Status:
COMPLETED
Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results
Lead Sponsor:
Elesta S.R.L.
Conditions:
Thyroid Nodule
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- The presence of a single nodule or dominating nodule;
- A solid or mixed echo-structure with less than 20% fluid volume;
- A lesion volume between 5 and 18 ml (greatest diameter \> 3.0 cm and \<= 4 cm);
- Thyroid hormone and TSH serum levels within the normalcy value;
- 2 cytologically negative examinations for suspected neoplasia (British Thyroid Association, Second class THY)within the last six months;
- Calcitonin values within the normalacy value;
- Anticoagulant treatment suspension and antiaggregation treatment suspended for at least 72 hours.
Exclusion
- Hyperfunctioning lesion (99mTc scintigraph);
- Autoimmune thyreopathy or elevation of autoantibodies;
- Active anticoagulant treatment or antiaggregation treatment.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00858104
Start Date
November 1 2008
End Date
May 1 2013
Last Update
May 26 2014
Active Locations (4)
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1
Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia
Perugia, Perugia, Italy, 06126
2
Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello
Pisa, Pisa, Italy, 56124
3
Arcispedale S. Maria Nuova
Reggio Emilia, Reggio Emilia, Italy, 42100
4
Ospedale Regina Apostolorum
Albano Laziale, Roma, Italy, 00041