Benign Breast Conditions; Breast FibroadenomasABLATENCT00807924
American Breast Laser Ablation Therapy Evaluation
An observational study of Benign Breast Conditions; Breast Fibroadenomas, run by Novian Health Inc. at 1 site in United States.
Trial summary
The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Benign Breast Conditions; Breast Fibroadenomas
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to 8 Aug 2018
- 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 undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.
Who may be able to join
- Diagnosis confirmed by needle core biopsy
- Tumors detected either by physical exam or imaging
- Tumors do not exceed 2 cm in diameter and measure at least 0.5 cm away from the skin and chest wall
- Single, multiple and/or bilateral tumors
- Patient has given consent prior to being treated with Novilase™
Who cannot join
- Patient is pregnant or lactating
- Hypercellularity suggestive of phyllodes
- Atypia
- Equivocal pathology report (e.g., discordance between radiographic and microscopic results)
- Fibroadenomas with stromal solidarity
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center - Department of Surgery
New York, New York, 10032
About this study
Official title: American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application
The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.
Read the detailed description
ABLATE is a prospective, observational multi-center tracking database which will evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked.
- Keywords
- Fibroadenomas, Papillomas, Breast, Minimally invasive, Interstitial laser therapy, Laser ablation, Benign, Non-cancerous, Breast lesion, Breast tumor
- Medical subject headings
- Fibroadenoma, Papilloma, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To monitor and measure long term safety and effectiveness Novilase
Measured: ongoing
To help refine, improve and/or validate breast tumor best practices and standard of care
Measured: ongoing
To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols
Measured: ongoing
To support the medical and patient communities through transparency--by contributing and publishing relevant, useful and meaningful data to support the development and design of future research
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startDec 2008
- Primary completion28 Aug 2017
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Breast Conditions; Breast FibroadenomasStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novian Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret Chen, MD, Principal investigator, Optum ProHealthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807924
- Sponsor's protocol ID
- BR001
- Acronym
- ABLATE
- Status last verified
- Aug 2023
- First submitted
- 11 Dec 2008
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Dowlatshahi K, Wadhwani S, Alvarado R, Valadez C, Dieschbourg J. Interstitial laser therapy of breast fibroadenomas with 6 and 8 year follow-up. Breast J. 2010 Jan-Feb;16(1):73-6. doi: 10.1111/j.1524-4741.2009.00830.x. Epub 2009 Oct 12.
PubMed 19825000Schwartzberg B, Lewin J, Abdelatif O, Bernard J, Bu-Ali H, Cawthorn S, Chen-Seetoo M, Feldman S, Govindarajulu S, Jones L, Juette A, Kavia S, Maganini R, Pain S, Shere M, Shriver C, Smith S, Valencia A, Whitacre E, Whitney R. Correction to: Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations. Ann Surg Oncol. 2018 Dec;25(Suppl 3):998. doi: 10.1245/s10434-018-6861-3.
PubMed 30298314
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application
- ClinicalTrials.gov ID
- NCT00807924
- Acronym / sponsor ID
- ABLATE / BR001
- Keywords
- Fibroadenomas, Papillomas, Breast, Minimally invasive, Interstitial laser therapy, Laser ablation, Benign, Non-cancerous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Novian Health Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 12 Dec 2008 (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.
The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.
Detailed description
ABLATE is a prospective, observational multi-center tracking database which will evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.
Key inclusion criteria (5 listed)
- Diagnosis confirmed by needle core biopsy
- Tumors detected either by physical exam or imaging
- Tumors do not exceed 2 cm in diameter and measure at least 0.5 cm away from the skin and chest wall
- Single, multiple and/or bilateral tumors
- Patient has given consent prior to being treated with Novilase™
Key exclusion criteria (5 listed)
- Patient is pregnant or lactating
- Hypercellularity suggestive of phyllodes
- Atypia
- Equivocal pathology report (e.g., discordance between radiographic and microscopic results)
- Fibroadenomas with stromal solidarity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To monitor and measure long term safety and effectiveness Novilase
Time frame: ongoing
To help refine, improve and/or validate breast tumor best practices and standard of care
Time frame: ongoing
To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols
Time frame: ongoing
To support the medical and patient communities through transparency--by contributing and publishing relevant, useful and meaningful data to support the development and design of future research
Time frame: ongoing
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 4 Aug 2023.
- Background: PubMed 19825000Dowlatshahi K, Wadhwani S, Alvarado R, Valadez C, Dieschbourg J. Interstitial laser therapy of breast fibroadenomas with 6 and 8 year follow-up. Breast J. 2010 Jan-Feb;16(1):73-6. doi: 10.1111/j.1524-4741.2009.00830.x. Epub 2009 Oct 12.
- Background: PubMed 30298314Schwartzberg B, Lewin J, Abdelatif O, Bernard J, Bu-Ali H, Cawthorn S, Chen-Seetoo M, Feldman S, Govindarajulu S, Jones L, Juette A, Kavia S, Maganini R, Pain S, Shere M, Shriver C, Smith S, Valencia A, Whitacre E, Whitney R. Correction to: Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations. Ann Surg Oncol. 2018 Dec;25(Suppl 3):998. doi: 10.1245/s10434-018-6861-3.
- Sponsor websiteLink provided by the sponsor.
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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.
Margaret Chen, MD principal investigator
Optum ProHealthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Breast Conditions; Breast Fibroadenomas, run by Novian Health Inc. at 1 site in United States.
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 5 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To monitor and measure long term safety and effectiveness Novilase (time frame: ongoing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00807924, which also lists 2 linked publications.
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 4 Aug 2023.