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 range18 Years

SexFEMALE

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)
✕. 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

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