Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.
This is a single arm prospective study. Approximately 4 investigational sites will enroll and follow subjects who meet the study criteria.The study will span a total of approximately 18 months: an estimated 6 months for recruitment and 12 months for follow up. 50 subjects will be enrolled in the study. It is anticipated that given an average of 1.5 operated breasts per subject enrolled for Revision Augmentation surgery that 75 implantations of SERI® surgical scaffold will occur.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SERI® scaffold implanted breasts | Experimental | SERI® Surgical Scaffold is a knitted, multifilament, bioengineered, silk mesh. It is mechanically strong, biocompatible, BIOSILK® purified, and long term bioresorbable. SERI® Surgical Scaffold is a sterile, single use only mesh and is supplied as a 10 x 25 cm sheet. SERI® Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold like) construction of its mesh. When long term bioresorption occurs and the patient's own tissue replaces the implanted scaffold over time the mechanical integrity of the repair is maintained. SERI® Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SERI® Surgical Scaffold | Device | Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly. |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. | This refers to the proportion of implanted breasts that will require reoperation for the recurrence of the initial cause of the increase in nipple to inframammary fold distance at the end of the 12-month follow-up period. Reoperation rate outcomes are presented as number of implanted breasts that required a reoperation out of the overall number of units analyzed. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months | This refers to the proportion of implanted breasts that will require reoperation for any cause at the end of the 12 month follow up period. The outcome is presented as the number of implanted breasts that required reoperation from the overall number of units analyzed. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Kind | Kind Chang Plastic Surgery - California Pacific Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mofid Plastic Surgery | La Jolla | California | 92037 | United States | ||
| Kind Chang Plastic Surgery - California Pacific Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SERI® Surgical Scaffold Implanted Breasts | SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SERI® Surgical Scaffold Implanted Breasts | SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. | This refers to the proportion of implanted breasts that will require reoperation for the recurrence of the initial cause of the increase in nipple to inframammary fold distance at the end of the 12-month follow-up period. Reoperation rate outcomes are presented as number of implanted breasts that required a reoperation out of the overall number of units analyzed. | Posted | Number | 95% Confidence Interval | Implanted breasts | 12 months | Implanted breasts | Implanted breasts |
|
Adverse event data was collected over 12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SERI® Surgical Scaffold Implanted Breasts | SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast complication associated with device | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Sofregen | 4029991564 | fjawed@sofregen.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AE Incidence Rates (Per Implanted Breast) at 30 Days | This refers to the AE incidence rate per implanted breast at thirty days. Outcome is reported as the number of adverse events reported for the overall number of units analyzed. | 30 days |
| AE Incidence Rates (Per Implanted Breast) at 12 Months | This refers to the AE incidence rate per implanted breast at twelve months. Outcome is reported as the number of adverse events reported for the overall number of units analyzed. | 12 months |
| Change in Mammometry From Baseline to 12 Months (Per Implanted Breast) | Mammometry is defined as standardized breast measurements. Mammometry was performed by direct measurement (ie with measuring tape) and indirectly through VECTRA imaging. | 12 months |
| Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient) | The BREAST-Q is a self-administered questionnaire developed at the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. This instrument specifically measured subject satisfaction and health related quality of life (QoL) following different types of breast surgery (reconstruction,augmentation, reduction, and mastectomy only). A subset of 4 scales from the augmentation module (Satisfaction with breasts, Satisfaction with outcome, Psychosocial wellbeing and Sexual wellbeing) were used in this study. In accordance with the BREAST-Q manual, subject scores were transformed into linearized measurements on a 0 to 100 scale, using the QScore software which was developed based on the Rasch model. For the transformed scores, a higher score indicated greater satisfaction or higher function. | 12 months |
| San Francisco |
| California |
| 94114 |
| United States |
| Somerset Plastic Surgery | Troy | Michigan | 48084 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Plastic Surgery Clinic | Mountlake Terrace | Washington | 98043 | United States |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Subjects who presented with Fold Malposition as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
|
|
| Secondary | Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months | This refers to the proportion of implanted breasts that will require reoperation for any cause at the end of the 12 month follow up period. The outcome is presented as the number of implanted breasts that required reoperation from the overall number of units analyzed. | Posted | Number | 95% Confidence Interval | Implanted breasts | 12 months | Implanted breasts | Implanted breasts |
|
|
|
| Secondary | AE Incidence Rates (Per Implanted Breast) at 30 Days | This refers to the AE incidence rate per implanted breast at thirty days. Outcome is reported as the number of adverse events reported for the overall number of units analyzed. | Posted | Number | 95% Confidence Interval | Adverse events | 30 days | Implanted breasts | Implanted breasts |
|
|
|
| Secondary | AE Incidence Rates (Per Implanted Breast) at 12 Months | This refers to the AE incidence rate per implanted breast at twelve months. Outcome is reported as the number of adverse events reported for the overall number of units analyzed. | Posted | Number | 95% Confidence Interval | Adverse events | 12 months | Implanted breasts | Implanted breasts |
|
|
|
| Secondary | Change in Mammometry From Baseline to 12 Months (Per Implanted Breast) | Mammometry is defined as standardized breast measurements. Mammometry was performed by direct measurement (ie with measuring tape) and indirectly through VECTRA imaging. | Posted | Mean | Standard Deviation | cm | 12 months | Implanted breasts | Implanted breasts |
|
|
|
| Secondary | Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient) | The BREAST-Q is a self-administered questionnaire developed at the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. This instrument specifically measured subject satisfaction and health related quality of life (QoL) following different types of breast surgery (reconstruction,augmentation, reduction, and mastectomy only). A subset of 4 scales from the augmentation module (Satisfaction with breasts, Satisfaction with outcome, Psychosocial wellbeing and Sexual wellbeing) were used in this study. In accordance with the BREAST-Q manual, subject scores were transformed into linearized measurements on a 0 to 100 scale, using the QScore software which was developed based on the Rasch model. For the transformed scores, a higher score indicated greater satisfaction or higher function. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| 0 |
| 34 |
| 1 |
| 34 |
| 13 |
| 34 |
| Breast mass | Reproductive system and breast disorders | Systematic Assessment |
|
| Breast haematoma | Reproductive system and breast disorders | Systematic Assessment |
|
| Breast swelling | Reproductive system and breast disorders | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Suture rupture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Physical breast examination abnormal | Investigations | Systematic Assessment |
|
| Physical examination abnormal | Investigations | Systematic Assessment |
|
| Breast complication associated with device | General disorders | Systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | Systematic Assessment |
|
| Mastitis | Infections and infestations | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Cutaneous contour deformity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided