Prophylactic MastectomyNCT02614885
Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue
An observational study of Prophylactic Mastectomy, run by Innoblative Designs, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prophylactic Mastectomy
- What is being tested?
- RFA
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2016to 17 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for prophylactic mastectomy.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Prophylactic Mastectomy
- Being tested
- RFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFADevice
Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Mastectomy | Females undergoing prophylactic mastectomy with RFA performed on the excised tissue. Receives: Device: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start20 Jul 2016
- Primary completion15 Jun 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylactic MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innoblative Designs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Daniela A Ochoa, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614885
- Sponsor's protocol ID
- 2015-01
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue
- ClinicalTrials.gov ID
- NCT02614885
- Acronym / sponsor ID
- 2015-01
- Conditions
- Prophylactic Mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Innoblative Designs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Arkansas
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Mastectomy | – | Device: RFAFemales undergoing prophylactic mastectomy with RFA performed on the excised tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for prophylactic mastectomy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFARadiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue. | Device | Prophylactic Mastectomy |
Primary outcome
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.
Time frame: Two weeks after surgery
Histologic analysis of ablation depth around the cavity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela A Ochoa, MD principal investigator
UAMS
Questions about this trial
What is this clinical trial studying?
An observational study of Prophylactic Mastectomy, run by Innoblative Designs, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Two weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.