Breast CarcinomaNCT03657069
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
A study testing Blossom and Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire in people with Breast Carcinoma and Breast Disorder, run by Stanford University at 1 site in United States.
Trial summary
This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Breast Disorder
- What is being tested?
- Blossom and Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 19 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., BRCA mutation and/or strong family history of breast cancer), both unilateral or bilateral mastectomy
- No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation
- Ability to understand and the willingness to sign a written informed consent document
- No life expectancy restrictions
- Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
- No requirements for organ and marrow function
Who cannot join
- Recent steroid use
- No major medical comorbidities (defined as American Society of Anesthesiologists [ASA] III or greater)
- No connective tissue disorder
- Prior breast surgery, excluding biopsy and lumpectomy
- History of or plan for breast radiation
- Pregnancy and nursing patients will be excluded from the study
Show all 11Show fewer
- No restrictions regarding use of other investigational agents
- No exclusion criteria related to history of allergic reactions
- No exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent
- No other agent-specific exclusion criteria
- No exclusion of cancer survivors or those who are human immunodeficiency virus (HIV)-positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94304
About this study
Official title: A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)
This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction.
SECONDARY OBJECTIVES:
- Patient satisfaction. II. Patient self-reported pain. III. Incidence of complications.
OUTLINE:
After mastectomy, participants undergo 2-staged implant-based breast reconstruction (IBR) with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.
After completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months
- Conditions
- Breast Carcinoma, Breast Disorder
- Being tested
- Blossom, Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlossomDevice
Also called Blossom Smart Expander Technology (Syringe Assist Device)
Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology
Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaireOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Blossom Smart Expander Technology) | Experimental | After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant. Receives: Device: Blossom; Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved
Measured by calculating the number of days from expander placement to achievement of desired expansion volume. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
Measured: Assessed weekly for up to 12 weeks
Secondary outcomes (5)
BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score
Defined as patient satisfaction with expansion process. Score range: 1 to 5 (5=very satisfied, 4=somewhat satisfied, 3=neutral, 2=somewhat dissatisfied, 1=very dissatisfied). Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. Scores were averaged to create an overall score.
Measured: Assessed weekly for up to 12 weeks
Number of Participants With Major Complications Associated With Tissue Expansion Process
Anticipated complications include Expander Extrusion, Wound Breakdown, and/or Infection. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
Measured: Assessed weekly for up to 12 weeks
Number of Participants With Minor Complications Associated With Tissue Expansion Process
Anticipated complications include Expander Extrusion, Wound Breakdown, and/or Infection. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
Measured: Assessed weekly for up to 12 weeks
Number of Participants With Device Malfunction Associated With Tissue Expansion Process
Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
Measured: Assessed weekly for up to 12 weeks
Pain Score
Self-reported pain associated with expansion process. Patients will be asked to rank pain level on a scale of 0 to 10, with 0 being the least pain and 10 being the most pain. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. Scores were averaged to create an overall score.
Measured: Assessed weekly for up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Aug 2018
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dung Nguyen, Stanford University
- Investigators
- Dung Nguyen, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657069
- Sponsor's protocol ID
- IRB-44367
- Other IDs
- NCI-2018-01702, BRS0088
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2018
- Last updated
- 22 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)
- ClinicalTrials.gov ID
- NCT03657069
- Acronym / sponsor ID
- IRB-44367
- Conditions
- Breast Carcinoma, Breast Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.
Detailed description
PRIMARY OBJECTIVES:
- To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction.
SECONDARY OBJECTIVES:
- Patient satisfaction. II. Patient self-reported pain. III. Incidence of complications.
OUTLINE:
After mastectomy, participants undergo 2-staged implant-based breast reconstruction (IBR) with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.
After completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Blossom Smart Expander Technology) | Experimental | Device: Blossom, Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaireAfter mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., BRCA mutation and/or strong family history of breast cancer), both unilateral or bilateral mastectomy
- No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation
- Ability to understand and the willingness to sign a written informed consent document
- No life expectancy restrictions
- Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
Key exclusion criteria (11 listed)
- Recent steroid use
- No major medical comorbidities (defined as American Society of Anesthesiologists [ASA] III or greater)
- No connective tissue disorder
- Prior breast surgery, excluding biopsy and lumpectomy
- History of or plan for breast radiation
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 |
|---|---|---|
| BlossomAlso: Blossom Smart Expander Technology (Syringe Assist Device)Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology | Device | Supportive care (Blossom Smart Expander Technology) |
| Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaireAncillary studies | Other | Supportive care (Blossom Smart Expander Technology) |
Primary outcome
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved
Time frame: Assessed weekly for up to 12 weeks
Measured by calculating the number of days from expander placement to achievement of desired expansion volume. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
5 secondary outcomes
BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score
Time frame: Assessed weekly for up to 12 weeks
Number of Participants With Major Complications Associated With Tissue Expansion Process
Time frame: Assessed weekly for up to 12 weeks
Number of Participants With Minor Complications Associated With Tissue Expansion Process
Time frame: Assessed weekly for up to 12 weeks
Number of Participants With Device Malfunction Associated With Tissue Expansion Process
Time frame: Assessed weekly for up to 12 weeks
Pain Score
Time frame: Assessed weekly for up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dung Nguyen principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blossom and Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire in people with Breast Carcinoma and Breast Disorder, run by Stanford University 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 6 inclusion and 11 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 22 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved (time frame: Assessed weekly for up to 12 weeks). 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 22 Jan 2024.