Microwave Ablation of Breast Tumors

Withdrawn

• Conditions: Breast Cancer
• Interventions: Device: Microwave Ablation/ Coagulation Arm

• Registration Number: NCT04828044
• Lead Sponsor: St. Joseph Hospital of Orange

Brief Summary

The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.

Detailed Description

Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy due to improvements in technology, reduced costs and reduced morbidity. The main objective of this protocol is to determine the extent of ablation based on time and power parameters of the MedWaves in breast cancers. This would be accomplished in patients diagnosed with breast cancer who are already scheduled for breast cancer surgery. Prior to the surgical removal of the cancer, the microwave antenna would be inserted into the tumor under ultrasound guidance (either percutaneously or open). The tumor would be ablated, and then surgically resected in a standard, curative fashion.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-30
• Last Update Submitted: 2021-03-30
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
• Tumor is palpable or visible on ultrasound or both
• All participants need to be fully able to give informed consent

Exclusion Criteria

• Gender: male
• Mental or legal incompetence
• Impaired decision-making capacity
• Pregnant women may not participate
• Implanted Pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Microwave Ablation/ Coagulation Arm	Microwave Ablation/ Coagulation Arm	These patients will receive microwave ablation using MedWaves Microwave Ablation/ Coagulation System.

Primary Outcome Measures

Name	Time	Method
Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System.	30 days	Measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation System through pathological review of destruction.

Secondary Outcome Measures

Name	Time	Method
Amount of toxicity of microwave ablation in patients.	30 Days	Measure toxicity of Microwave Ablation through patient follow-up and assessment.
Provide the differences between percutaneous and open Microwave Ablation	30 Days	Evaluate differences between percutaneous and open Microwave Ablation through pathological review and patient follow-up.

Trial Locations

Locations (1)

St. Joseph Hospital of Orange; 🇺🇸 Orange, California, United States