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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03657069

Enrollment

Registered

2018-09-04

Start date

2018-08-01

Completion date

2020-08-19

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma, Breast Disorder

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

Interventions

DEVICEBlossom

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

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

Ancillary studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved	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.

Secondary

Measure	Time frame	Description
BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score	Assessed weekly for up to 12 weeks	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.
Number of Participants With Major Complications Associated With Tissue Expansion Process	Assessed weekly for up to 12 weeks	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.
Number of Participants With Minor Complications Associated With Tissue Expansion Process	Assessed weekly for up to 12 weeks	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.
Number of Participants With Device Malfunction Associated With Tissue Expansion Process	Assessed weekly for up to 12 weeks	Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
Pain Score	Assessed weekly for up to 12 weeks	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Supportive Care (Blossom Smart Expander Technology) After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.	11
Total	11

Baseline characteristics

Characteristic	Supportive Care (Blossom Smart Expander Technology)
Age, Continuous	46 years
Body Mass Index (BMI)	20.6 kg/m^2
Race/Ethnicity, Customized Asian	3 Participants
Race/Ethnicity, Customized Caucasian	5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants
Region of Enrollment United States	11 Participants
Sex: Female, Male Female	11 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 11
other Total, other adverse events	1 / 11
serious Total, serious adverse events	1 / 11

Outcome results

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.