Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

Vetëm përdoruesit e regjistruar mund të përkthejnë artikuj

Identifikohuni Regjistrohu

Lidhja ruhet në kujtesën e fragmenteve

StatusiPërfunduar

Sponsorët

David R. Brenin, MD

Bashkëpunëtorë

Theraclion SAS, Paris, France

TRAJTIM KLINIKAL: NCT02078011

BioSeek: nct02078011

Fjalë kyçe

Abstrakt

The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).

This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.

Datat

Verifikuar së fundmi:	04/30/2018
Paraqitur së pari:	02/24/2014
Regjistrimi i vlerësuar u dorëzua:	02/27/2014
Postuar së pari:	03/03/2014
Përditësimi i fundit i paraqitur:	04/30/2018
Përditësimi i fundit i postuar:	05/06/2018
Data e fillimit të studimit aktual:	03/31/2014
Data e vlerësuar e përfundimit primar:	08/28/2016
Data e vlerësimit të përfundimit të studimit:	09/30/2017

Gjendja ose sëmundja

Breast Fibroadenoma

Ndërhyrja / trajtimi

Device: HIFU treatment

Faza

Grupet e krahëve

Krah	Ndërhyrja / trajtimi
Experimental: HIFU treatment The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die	Device: HIFU treatment The Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast).

Kriteret e pranimit

Moshat e pranueshme për studim	18 Years Për të 18 Years
Gjinitë e pranueshme për studim	Female
Pranon Vullnetarë të Shëndetshëm	po
Kriteret	Inclusion Criteria: - Diagnosis of fibroadenoma with histological confirmation of fibroadenoma of the breast - Fibroadenoma is palpable - Fibroadenoma is 1 cm or greater at its largest dimension and no less than 9 mm in the anterior-posterior dimension - Fibroadenoma volume is between 2 cc and 10 cc - Patient must give written informed consent (personally signed and dated) before completing any study-related procedure Exclusion Criteria: - Patient is pregnant or nursing - Patient with breast implants in the target breast - Patient with a breast cyst within the fibroadenoma to be treated - Patient participating in another clinical trial involving an investigational drug, device or biologic

Rezultati

Masat Kryesore të Rezultateve

1. Change in volume of fibroadenoma [baseline, 3, 6, and 12 months]

Fibroadenoma volume with be measured by ultrasound.

2. Size of fibroadenoma [baseline, 3, 6, and 12 months]

Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.

3. Patient reported outcomes [up to 12 months]

Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session

Masat dytësore të rezultateve

1. Incidence of adverse events [up to 12 months]