Trial Outcomes & Findings for Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy (NCT NCT03657069)

NCT ID: NCT03657069

Last Updated: 2024-01-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Assessed weekly for up to 12 weeks
• Results posted on: 2024-01-22

Participant Flow

Unit of analysis: breasts

Participant milestones

Measure	Supportive Care (Blossom Smart Expander Technology) After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology comprised of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.
Overall Study STARTED	11 22
Overall Study COMPLETED	11 22
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Supportive Care (Blossom Smart Expander Technology) n=11 Participants After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
Age, Continuous	46 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants
Body Mass Index (BMI)	20.6 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Blossom Smart Expander Technology) n=11 Participants After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved	13 days Interval 8.0 to 18.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Blossom Smart Expander Technology) n=11 Participants After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score	4.8 score on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Blossom Smart Expander Technology) n=22 breasts After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
Number of Participants With Major Complications Associated With Tissue Expansion Process Infection requiring IV antibiotics	0 breasts
Number of Participants With Major Complications Associated With Tissue Expansion Process Infection resulting in TE removal	1 breasts
Number of Participants With Major Complications Associated With Tissue Expansion Process Any other issues requiring surgical intervention	0 breasts

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Blossom Smart Expander Technology) n=22 breasts After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
Number of Participants With Minor Complications Associated With Tissue Expansion Process Seroma	1 breasts
Number of Participants With Minor Complications Associated With Tissue Expansion Process Hematoma	0 breasts
Number of Participants With Minor Complications Associated With Tissue Expansion Process Infection resolved with oral antibiotics	0 breasts
Number of Participants With Minor Complications Associated With Tissue Expansion Process Dehiscence, skin breakdown, etc.	0 breasts

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Blossom Smart Expander Technology) n=22 breasts After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
Number of Participants With Device Malfunction Associated With Tissue Expansion Process	0 breasts

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Blossom Smart Expander Technology) n=11 Participants After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
Pain Score	1.27 score on a scale Standard Deviation 1.35

Adverse Events

Supportive Care (Blossom Smart Expander Technology)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Supportive Care (Blossom Smart Expander Technology) n=11 participants at risk After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
Infections and infestations Infection	9.1% 1/11 • Up to 12 months

Other adverse events

Measure	Supportive Care (Blossom Smart Expander Technology) n=11 participants at risk After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.
Skin and subcutaneous tissue disorders Seroma	9.1% 1/11 • Up to 12 months

Additional Information

Dung Nguyen, MD, PharmD, FACS

Stanford University

Phone: (650) 498-6004

Email: nguyendh@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place