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Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy

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ClinicalTrials.gov Identifier: NCT03657069
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Breast Disorder Device: Blossom Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction.

SECONDARY OBJECTIVES:

I. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive care (Blossom Smart Expander Technology)
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.
Device: Blossom
Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology
Other Name: Blossom Smart Expander Technology (Syringe Assist Device)

Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
Ancillary studies




Primary Outcome Measures :
  1. Time to full expansion defined as number of days until desired breast tissue expansion volume is achieved [ Time Frame: Up to 12 months ]
    Will be measured by calculating the number of days from expander placement to achievement of desired expansion volume. Measurement time points include date of expander placement and date that desired expansion volume is reached. The primary outcome values will be compared to values commonly reported in the literature in conventional 2-staged implant-based breast reconstruction (IBR).


Secondary Outcome Measures :
  1. Patient satisfaction defined as patient satisfaction with expansion process [ Time Frame: Up to 12 months ]
    Will be measured by non-validated surveys (Breast questionnaire [Q]- Reconstruction module (preoperative) Version 2.0) administered to patients in clinic in order to assess satisfaction. Patients will be asked to rank satisfaction on the following scale: very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied. Measurement time points will be at postoperative clinic visits, which will occur at weekly and intervals during the expansion process. Survey data will be tabulated.

  2. Incidence of complications defined as complications associated with tissue expansion process, including expander extrusion, wound breakdown, infection, and/or device malfunction [ Time Frame: Up to 12 months ]
    Will be measured by assessment of these patients at postoperative clinic visits for these complications. Measurement time points will be at postoperative clinic visits, which will occur at weekly intervals during the expansion process. The data will be compared to values commonly reported in the literature in conventional 2-staged implant-based breast reconstruction (IBR).

  3. Pain with expansion defined as self-reported pain associated with expansion process [ Time Frame: Up to 12 months ]
    Will be measured by non-validated surveys (Breast Q) administered to patients in clinic in order to assess pain. Patients will be asked to rank pain level on a scale of 0 to 10, with 0 being the least and 10 being the most. Measurement time points will be at postoperative clinic visits, which will occur at weekly intervals during the expansion process. Survey data will be tabulated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657069


Contacts
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Contact: Shannon Meyer 650-724-1953 smeyer27@stanford.edu

Locations
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United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94304
Contact: Shannon Meyer    650-724-1953    smeyer27@stanford.edu   
Principal Investigator: Dung H Nguyen         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Dung Nguyen Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03657069    
Other Study ID Numbers: IRB-44367
NCI-2018-01702 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRS0088 ( Other Identifier: OnCore )
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases