CompletedNot Applicable

Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

11 participantsStarted 2016-07-20

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. The patient is receiving a skin sparing mastectomy(s)
. The patient has had previous exposure to chemotherapy or radiation therapy
. The patient has implants in the breast(s) to be included in the study
. The patient is currently pregnant or lactating
. 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)
. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Histologic measurement of cavitary ablation lesions created by the Innoblative radiofrequency ablation device in ex vivo breast tissue to correlate ablation size with ablation parameters.

Timeframe: Two weeks after surgery

Trial details

NCT IDNCT02614885

SponsorInnoblative Designs, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-06-15

View on ClinicalTrials.gov More Prophylactic Mastectomy trials