Local Treatment by Thermic Destruction of Primitive Breast Cancer

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

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-09

Study Completion Date

2016-11-17

Brief Summary

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Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with breast cancer smaller than 20mm

Group Type EXPERIMENTAL

Thermic destruction of tissue by Laser using the Novilase device

Intervention Type PROCEDURE

Interventions

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Thermic destruction of tissue by Laser using the Novilase device

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Noninflammatory unilateral and unifocal breast cancer
* Size \</= 20mm (ultrasound measure)
* Histological confirmation of cancer by biopsy grade status hormone and HER2.
* Good delineation of the lesion on ultrasound.
* Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
* Age between 18 and 80
* ECOG performance status 0 or 1

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No