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

NCT ID: NCT03657069

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-08-19

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

Conditions

Breast Carcinoma; Breast Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blossom

Intervention Type: DEVICE

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

Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire

Intervention Type: OTHER

Ancillary studies

Interventions

Blossom

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

Intervention Type: DEVICE

Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Blossom Smart Expander Technology (Syringe Assist Device)

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 of cancer survivors or those who are human immunodeficiency virus (HIV)-positive

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Dung Nguyen

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dung Nguyen

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2018-01702

Identifier Type: REGISTRY

Identifier Source: secondary_id

BRS0088

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-44367

Identifier Type: -

Identifier Source: org_study_id