Trial Outcomes & Findings for Becker Continued Access Study (NCT NCT01286870)
NCT ID: NCT01286870
Last Updated: 2019-03-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
4 Years
Results posted on
2019-03-06
Participant Flow
The Becker CA Study was an open-label, multi-center study to provide continued physician and patient experience with the smooth Becker 25 and 50 Expander/Breast Implant. Subjects included women who required primary breast reconstruction.
Participant milestones
| Measure |
Reconstruction
The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.
The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort.
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|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
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11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Becker Continued Access Study
Baseline characteristics by cohort
| Measure |
Reconstruction
n=11 Participants
The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.
The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 YearsPopulation: The study was prematurely discontinued. The sample size was not large enough for statistical significance. Because only 11 subjects were enrolled in the Becker CA Study, demographic information and key safety information were listed by subject only and no formal summary tables were prepared.
Outcome measures
| Measure |
Reconstruction
n=11 Participants
The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.
The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort.
|
|---|---|
|
Safety by Incidence, Severity, and Duration of Adverse Events
Number of Adverse Events (AEs)
|
33 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
Mild AEs
|
32 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
Moderate AEs
|
1 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
Severe AEs
|
0 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
Ongoing AEs at end of trial
|
6 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
Resolved AEs
|
27 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
AE resolution the same day as AE onset
|
5 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
AE resolution in 1 week (1-7 days)
|
12 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
AE resolution in 2 weeks (8-14 days)
|
1 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
AE resolution over 3 months (90+ days)
|
3 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
AE resolution in 2-4 weeks (15-30 days)
|
3 Events
|
|
Safety by Incidence, Severity, and Duration of Adverse Events
AE resolution in 1-3 months (30-90 days)
|
3 Events
|
PRIMARY outcome
Timeframe: 4 YearsPopulation: The study was prematurely discontinued. The sample size was not large enough for statistical significance. Because only 11 subjects were enrolled in the Becker CA Study, demographic information and key safety information were listed by subject only and no formal summary tables were prepared.
Outcome measures
| Measure |
Reconstruction
n=11 Participants
The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.
The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort.
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|---|---|
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Safety by Method of Resolution of Adverse Events
Re-operation Procedures Without Explantation
|
16 Procedures
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Safety by Method of Resolution of Adverse Events
Re-operation Procedures With Explantation
|
9 Procedures
|
Adverse Events
Reconstruction
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reconstruction
n=11 participants at risk
The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction.
The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort.
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|---|---|
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General disorders
Delayed Wound Healing
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36.4%
4/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
General disorders
Grade III Capsular Contracture
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45.5%
5/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
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Infections and infestations
Infection
|
36.4%
4/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
General disorders
Wound Dehiscence
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
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|
Injury, poisoning and procedural complications
Breast - Unacceptably High Sensitivity
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Excess Tissue/Dog Ear
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
General disorders
Grade IV Capsular Contracture
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
General disorders
Seroma
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
General disorders
Extrusion
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Wrinkling
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Nipple - Unacceptably High Sensitivity
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Asymmetry
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Irritation/Inflammation
|
18.2%
2/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Hypertrophic Scarring
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Necrosis
|
27.3%
3/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Swelling (Excessive)
|
9.1%
1/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
General disorders
Size Change - Patient Request
|
18.2%
2/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
|
Injury, poisoning and procedural complications
Grade II Capsular Contracture w/Surgical
|
18.2%
2/11
Ten of the 11 subjects in the CA Study had one or more postoperative complications. Severity was mild for all but 1 moderate case of infection and 2 moderate cases of Grade III capsular contracture
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place