Feasibility Study of Cavitary Radiofrequency Ablation in... | NCT02614885

Studies
Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

NCT02614885

Sponsor

Innoblative Designs, Inc.

Status

Completed

Last Update Posted

Nov 14, 2017Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Prophylactic Mastectomy

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2016Actual

Primary Completion Date

Jun 15, 2017Actual

Completion Date

Aug 17, 2017Actual

First Submitted Date

Nov 20, 2015

First Submission Date that Met QC Criteria

Nov 23, 2015

First Posted Date

Nov 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2017

Last Update Posted Date

Nov 14, 2017Actual

Name	Class
University of Arkansas	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prophylactic Mastectomy		Females undergoing prophylactic mastectomy with RFA performed on the excised tissue.	Device: RFA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RFA	Device	Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.	Prophylactic Mastectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Histologic analysis of ablation depth around the cavity.	Two weeks after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients presenting for prophylactic mastectomy.

Sampling Method

Non-Probability Sample