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

Breast Carcinoma Clinical Trial

Official title:

A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657069
• Other study ID #: IRB-44367
• Secondary ID: NCI-2018-01702BR
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: August 19, 2020

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Disorder
• Breast Neoplasms

Intervention

Device:
• Blossom
Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology

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

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed weekly for up to 12 weeks
Secondary	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.	Assessed weekly for up to 12 weeks
Secondary	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.	Assessed weekly for up to 12 weeks
Secondary	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.	Assessed weekly for up to 12 weeks
Secondary	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.	Assessed weekly for up to 12 weeks
Secondary	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.	Assessed weekly for up to 12 weeks