MedDataX Logo

Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

NCT ID: NCT02614885

Last Updated: 2017-11-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-20

Study Completion Date

2017-08-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single-arm, prospective study of a radiofrequency ablation device on the excised breast tissue of ten (10) prophylactic mastectomy patients. The ablation lesion created by the device will be analyzed histologically.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a single-center, prospective, open label study of a radiofrequency ablation device. 10 patients who are scheduled to undergo prophylactic mastectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. Once the breast tissue is removed, the radiofrequency ablation device will be used on the ex vivo tissue to ablate a lesion around a cavity created in the tissue. The ablation lesion will be characterized. The study period per subject is the time it takes to assess the ablation lesion histologically.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prophylactic Mastectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prophylactic Mastectomy

Females undergoing prophylactic mastectomy with RFA performed on the excised tissue.

RFA

Intervention Type DEVICE

Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RFA

Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Female
2. At least 18 years of age
3. Scheduled to receive a standard of care prophylactic mastectomy (or prophylactic bi-lateral mastectomy)
4. The patients' breast(s) to be included in the study are undiseased
5. The patient has adequate breast volume for ex vivo ablation procedure

Exclusion Criteria

1. The patient is receiving a skin sparing mastectomy(s)
2. The patient has had previous exposure to chemotherapy or radiation therapy
3. The patient has implants in the breast(s) to be included in the study
4. The patient is currently pregnant or lactating
5. The patient has tissue markers implanted in the breast to be included in the study (unless these can be removed when creating a cavity in the ex vivo breast tissue)
6. The patient has had previous surgery on the breast(s) to be included in the study (unless study investigator determines that this will not affect the validity of data in this study)
7. The patient in participating in any other clinical study of a device or drug that may impact the participant safety of the validity of data acquired in this study
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Arkansas

OTHER

Sponsor Role collaborator

Innoblative Designs, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniela A Ochoa, MD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-01

Identifier Type: -

Identifier Source: org_study_id