Radiofrequency Ablation (RFA) in Breast Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2025-09-09

Brief Summary

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To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.

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Detailed Description

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A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar.

Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure.

Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Radiofrequency ablation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency Ablation Tumor

Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode.

Group Type EXPERIMENTAL

Cool-tip electrode for Radiofrequency Ablation

Intervention Type DEVICE

Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable

Interventions

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Cool-tip electrode for Radiofrequency Ablation

Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Infiltrating ductal carcinoma according the biopsy of the breast,
* Tumor visible by ultrasound, smaller than 2 cm,
* Located \> 1 cm from the chest wall and the skin.