Breast Cancer FemaleNCT03718442
Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins
An observational study of Breast Cancer Female, run by Invuity, Inc..
Trial summary
The purpose of this study is to compare the qualitative severity and depth of dissection devices' associated thermal artifact in breast lumpectomy shaved margins between the use of electrocautery and low thermal energy dissection, PhotonBlade. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- PhotonBlade vs Bovie for lumpectomy shaved surgical margins
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2019to 15 Jun 2020
- 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: Women who have a diagnosis of breast cancer and undergo a lumpectomy
Who may be able to join
- have aged 18 years old or older.
- have DCIS or Invasive breast cancer that is eligible for breast-conserving surgery.
- have not had previous chest radiotherapy.
- understand the study purpose, requirements, and risks.
- able and willing to give informed consent.
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Low Energy Dissection Vs. Electrocautery Qualitative Severity and Depth of Thermal Artifact in Breast Cancer Lumpectomy Shaved Surgical Margins
The purpose of this study is to compare the qualitative severity and depth of dissection devices' associated thermal artifact in breast lumpectomy shaved margins between the use of electrocautery and low thermal energy dissection, PhotonBlade.
The investigators hypothesize that the use of PhotonBlade would result in a significantly lower qualitative severity and a shorter depth of thermal artifact in breast lumpectomies shaved margins, when compared to electrocautery devices.
Read the detailed description
When performing lumpectomy, surgeons have used electrocautery devices as dissecting tools. However, those devices use high thermal energy that might impact the margin cellular architecture and as such the quality of margin assessment by the pathologist. Moreover, recently, modern low thermal energy dissection devices have been introduced to the market. However, the impact of those devices on reducing the thermal injury/artifact on surgical margin has not been well investigated. 4,5 While Ruidaz et al. 2011 data suggest that using the traditional electrosurgical device in place of the low thermal-injury device results in 48% of the close margin samples being negatively converted to false-positive, and in 11% converting from close to false-negative, there is still a need for more studies to further characterize the utility of those devices. 6 PhotonBlade (Invuity, San Francisco, CA, USA) has been approved by United States Food and Drug Administration (FDA). PhotonBlade is a dynamic precision illuminator with enhanced energy delivery dissection device. The dynamic precision illumination is a thermally cool illumination technology that allows a uniformal illumination without glare or shadow. 7 The enhanced energy delivery technology allows low thermal spread, surgeon controlled edge temperature, and wet field use.7 As such, PhontonBlade allows better blade control for achieving adequate visualization, hemostasis, with a minimum collateral damage to the surgical margin tissue. The use of PhotonBlade demonstrated the least penetrating thermal tissue damage/spread when compared to other modern dissection devices (Valleylab Pencil, Valleylab EDGE Coated Pencil, PlasmaBlade 3.0S and PlasmaBlade 4.0).8
- Conditions
- Breast Cancer Female
- Being tested
- PhotonBlade vs Bovie for lumpectomy shaved surgical margins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotonBlade vs Bovie for lumpectomy shaved surgical marginsDevice
For each enrolled patient, six shaved margins will be obtained (superior, inferior, medial, lateral, anterior, and posterior). For each patient, electrocautery will be used to obtain 3 of the shaved margins, and PhotonBlade to obtain the other 3 shaved margins. Once the lumpectomy site shaved margins have been obtained, the shaved surgical margins will be evaluated by a pathologist whom is blinded in regards to the dissection device that was used for each margin. The pathologist will be evaluating each shaved margin and reporting the outcomes (qualitative severity and depth of thermal artifact)
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients - lumpectomy | Women who are 18 years or older, have Ductal carcinoma in situ (DCIS) or invasive breast-conserving surgery, have not had previous chest radiotherapy. 20 patients who meet above study population criteria will be enrolled in this study.Shaved margins for each lumpectomy site will be excised with either Bovie (3 sides) or PhotonBlade (3 sides) for each patient. The effect of PhotonBlade vs Bovie on pathology assessment of lumpectomy shaved surgical margins will be compared. Receives: Device: PhotonBlade vs Bovie for lumpectomy shaved surgical margins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of thermal artifact
The severity of the thermal artifact will be assessed by identifying the presence or absence of each the three qualitative severity zones, described previously,6 as below:
- Zone I: extensive charring tissue
- Zone II: fused cellular architecture
- Zone III: distressed cellular architecture
Measured: Through study completion, an average of 6 months
Depth of thermal artifact
The depth of the thermal artifact will be assessed by reporting the length in micrometer (μm) from the start of Zone 1 to the end of Zone III.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start15 Mar 2019 (estimated)
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invuity, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718442
- Sponsor's protocol ID
- 2018-8984
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No plan in place at this time.
Publications
ACS. Breast Cancer Facts and Figures 2011-2012. (2012).
Vila J, Gandini S, Gentilini O. Overall survival according to type of surgery in young (</=40 years) early breast cancer patients: A systematic meta-analysis comparing breast-conserving surgery versus mastectomy. Breast. 2015 Jun;24(3):175-81. doi: 10.1016/j.breast.2015.02.002. Epub 2015 Feb 23.
PubMed 25728282Pleijhuis RG, Graafland M, de Vries J, Bart J, de Jong JS, van Dam GM. Obtaining adequate surgical margins in breast-conserving therapy for patients with early-stage breast cancer: current modalities and future directions. Ann Surg Oncol. 2009 Oct;16(10):2717-30. doi: 10.1245/s10434-009-0609-z. Epub 2009 Jul 17.
PubMed 19609829Chiappa C, Rovera F, Corben AD, Fachinetti A, De Berardinis V, Marchionini V, Rausei S, Boni L, Dionigi G, Dionigi R. Surgical margins in breast conservation. Int J Surg. 2013;11 Suppl 1:S69-72. doi: 10.1016/S1743-9191(13)60021-7.
PubMed 24380558Ruidiaz ME, Cortes-Mateos MJ, Sandoval S, Martin DT, Wang-Rodriguez J, Hasteh F, Wallace A, Vose JG, Kummel AC, Blair SL. Quantitative comparison of surgical margin histology following excision with traditional electrosurgery and a low-thermal-injury dissection device. J Surg Oncol. 2011 Dec;104(7):746-54. doi: 10.1002/jso.22012. Epub 2011 Jul 8.
PubMed 21744349Haydon E. et al. Assessment of penetrating thermal tissue damage/spread associated with PhotonBlade™, Valleylab™ Pencil, Valleylab™ EDGE™ Coated Pencil, PlasmaBlade® 3.0S and PlasmaBlade® 4.0 for intraoperative tissue dissection using the fresh extirpated porcine muscle model
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Energy Dissection Vs. Electrocautery Qualitative Severity and Depth of Thermal Artifact in Breast Cancer Lumpectomy Shaved Surgical Margins
- ClinicalTrials.gov ID
- NCT03718442
- Acronym / sponsor ID
- 2018-8984
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Invuity, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Montefiore Medical Center
- Study start
- 15 Mar 2019 (estimated)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 24 Oct 2018 (actual)
- 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 study is to compare the qualitative severity and depth of dissection devices' associated thermal artifact in breast lumpectomy shaved margins between the use of electrocautery and low thermal energy dissection, PhotonBlade.
The investigators hypothesize that the use of PhotonBlade would result in a significantly lower qualitative severity and a shorter depth of thermal artifact in breast lumpectomies shaved margins, when compared to electrocautery devices.
Detailed description
When performing lumpectomy, surgeons have used electrocautery devices as dissecting tools. However, those devices use high thermal energy that might impact the margin cellular architecture and as such the quality of margin assessment by the pathologist. Moreover, recently, modern low thermal energy dissection devices have been introduced to the market. However, the impact of those devices on reducing the thermal injury/artifact on surgical margin has not been well investigated. 4,5 While Ruidaz et al. 2011 data suggest that using the traditional electrosurgical device in place of the low thermal-injury device results in 48% of the close margin samples being negatively converted to false-positive, and in 11% converting from close to false-negative, there is still a need for more studies to further characterize the utility of those devices. 6 PhotonBlade (Invuity, San Francisco, CA, USA) has been approved by United States Food and Drug Administration (FDA). PhotonBlade is a dynamic precision illuminator with enhanced energy delivery dissection device. The dynamic precision illumination is a thermally cool illumination technology that allows a uniformal illumination without glare or shadow. 7 The enhanced energy delivery technology allows low thermal spread, surgeon controlled edge temperature, and wet field use.7 As such, PhontonBlade allows better blade control for achieving adequate visualization, hemostasis, with a minimum collateral damage to the surgical margin tissue. The use of PhotonBlade demonstrated the least penetrating thermal tissue damage/spread when compared to other modern dissection devices (Valleylab Pencil, Valleylab EDGE Coated Pencil, PlasmaBlade 3.0S and PlasmaBlade 4.0).8
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients - lumpectomy | – | Device: PhotonBlade vs Bovie for lumpectomy shaved surgical marginsWomen who are 18 years or older, have Ductal carcinoma in situ (DCIS) or invasive breast-conserving surgery, have not had previous chest radiotherapy. 20 patients who meet above study population criteria will be enrolled in this study.Shaved margins for each lumpectomy site will be excised with either Bovie (3 sides) or PhotonBlade (3 sides) for each patient. The effect of PhotonBlade vs Bovie on pathology assessment of lumpectomy shaved surgical margins will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have a diagnosis of breast cancer and undergo a lumpectomy
Key inclusion criteria (5 listed)
- have aged 18 years old or older.
- have DCIS or Invasive breast cancer that is eligible for breast-conserving surgery.
- have not had previous chest radiotherapy.
- understand the study purpose, requirements, and risks.
- able and willing to give informed consent.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| PhotonBlade vs Bovie for lumpectomy shaved surgical marginsFor each enrolled patient, six shaved margins will be obtained (superior, inferior, medial, lateral, anterior, and posterior). For each patient, electrocautery will be used to obtain 3 of the shaved margins, and PhotonBlade to obtain the other 3 shaved margins. Once the lumpectomy site shaved margins have been obtained, the shaved surgical margins will be evaluated by a pathologist whom is blinded in regards to the dissection device that was used for each margin. The pathologist will be evaluating each shaved margin and reporting the outcomes (qualitative severity and depth of thermal artifact) | Device | Breast cancer patients - lumpectomy |
Primary outcome
Severity of thermal artifact
Time frame: Through study completion, an average of 6 months
The severity of the thermal artifact will be assessed by identifying the presence or absence of each the three qualitative severity zones, described previously,6 as below: * Zone I: extensive charring tissue * Zone II: fused cellular architecture * Zone III: distressed cellular architecture
Depth of thermal artifact
Time frame: Through study completion, an average of 6 months
The depth of the thermal artifact will be assessed by reporting the length in micrometer (μm) from the start of Zone 1 to the end of Zone III.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- BackgroundACS. Breast Cancer Facts and Figures 2011-2012. (2012).
- Background: PubMed 25728282Vila J, Gandini S, Gentilini O. Overall survival according to type of surgery in young (</=40 years) early breast cancer patients: A systematic meta-analysis comparing breast-conserving surgery versus mastectomy. Breast. 2015 Jun;24(3):175-81. doi: 10.1016/j.breast.2015.02.002. Epub 2015 Feb 23.
- Background: PubMed 19609829Pleijhuis RG, Graafland M, de Vries J, Bart J, de Jong JS, van Dam GM. Obtaining adequate surgical margins in breast-conserving therapy for patients with early-stage breast cancer: current modalities and future directions. Ann Surg Oncol. 2009 Oct;16(10):2717-30. doi: 10.1245/s10434-009-0609-z. Epub 2009 Jul 17.
- Background: PubMed 24380558Chiappa C, Rovera F, Corben AD, Fachinetti A, De Berardinis V, Marchionini V, Rausei S, Boni L, Dionigi G, Dionigi R. Surgical margins in breast conservation. Int J Surg. 2013;11 Suppl 1:S69-72. doi: 10.1016/S1743-9191(13)60021-7.
- Background: PubMed 21744349Ruidiaz ME, Cortes-Mateos MJ, Sandoval S, Martin DT, Wang-Rodriguez J, Hasteh F, Wallace A, Vose JG, Kummel AC, Blair SL. Quantitative comparison of surgical margin histology following excision with traditional electrosurgery and a low-thermal-injury dissection device. J Surg Oncol. 2011 Dec;104(7):746-54. doi: 10.1002/jso.22012. Epub 2011 Jul 8.
- BackgroundHaydon E. et al. Assessment of penetrating thermal tissue damage/spread associated with PhotonBlade™, Valleylab™ Pencil, Valleylab™ EDGE™ Coated Pencil, PlasmaBlade® 3.0S and PlasmaBlade® 4.0 for intraoperative tissue dissection using the fresh extirpated porcine muscle model
- Individual participant dataSharing planned: Undecided. No plan in place at this time.
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Invuity, 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 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennise D Dalma-Weiszhausz, PhD (6502486662, ddalma@invuity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of thermal artifact (time frame: Through study completion, an average of 6 months). The study lists 2 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 NCT03718442, which also lists 6 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 24 Oct 2018.