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

Primary Purpose

Breast Carcinoma, Breast Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blossom
Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (Blossom Smart Expander Technology)

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to full expansion defined as number of days until desired breast tissue expansion volume is achieved
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

Patient satisfaction defined as patient satisfaction with expansion process
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.
Incidence of complications defined as complications associated with tissue expansion process, including expander extrusion, wound breakdown, infection, and/or device malfunction
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).
Pain with expansion defined as self-reported pain associated with expansion process
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.

Full Information

First Posted
August 30, 2018
Last Updated
September 9, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03657069
Brief Title
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
Official Title
A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Breast Disorder

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (Blossom Smart Expander Technology)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Blossom
Other Intervention Name(s)
Blossom Smart Expander Technology (Syringe Assist Device)
Intervention Description
Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology
Intervention Type
Other
Intervention Name(s)
Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Time to full expansion defined as number of days until desired breast tissue expansion volume is achieved
Description
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).
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Patient satisfaction defined as patient satisfaction with expansion process
Description
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.
Time Frame
Up to 12 months
Title
Incidence of complications defined as complications associated with tissue expansion process, including expander extrusion, wound breakdown, infection, and/or device malfunction
Description
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).
Time Frame
Up to 12 months
Title
Pain with expansion defined as self-reported pain associated with expansion process
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Meyer
Phone
650-724-1953
Email
smeyer27@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dung Nguyen
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Meyer
Phone
650-724-1953
Email
smeyer27@stanford.edu
First Name & Middle Initial & Last Name & Degree
Dung H Nguyen

12. IPD Sharing Statement

Plan to Share IPD
No

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

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