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| Name | Class |
|---|---|
| Allergan Medical | INDUSTRY |
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Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.
Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduction, Mastopexy No Implant, No Seri | Active Comparator | Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used |
|
| Mastopexy, Implant no Seri Scaffold | Active Comparator | Mastopexy with implant, No Seri Surgical Scaffold support is used |
|
| Breast Reduction with Seri Support | Active Comparator | Patients undergoing breast reduction with the use of Seri Surgical scaffold support |
|
| Augmentation Mastopexy, Implant and Seri | Active Comparator | Augmentation Mastopexy patients where Seri Surgical scaffold is used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seri Surgical Scaffold | Device | An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nipple to Fold Measurement on Stretch | The Nipple to fold will be measured manually over time to 1 year | 1 year post op |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Breast Tissue Above Nipple | The percentage of breast tissue above and below the horizontal plane of the nipple over time | 1 year post op |
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Inclusion Criteria:
Age =>18 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley P Bengtson, MD | Bengtson Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bengtson Center for Aesthetics and Plastic Surgery | Grand Rapids | Michigan | 49503 | United States | ||
| Center for Aesthetics and Plastic Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduction, Mastopexy No Implant, No Seri | Patients undergoing reduction or mastopexy but no implant is used and no Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| FG001 | Mastopexy, Implant no Seri Scaffold | Mastopexy with implant, No Seri support is used Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| FG002 | Breast Reduction With Seri Support | Patients undergoing breast reduction with the use of Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| FG003 | Augmentation Mastopexy, Implant and Seri | Augmentation Mastopexy patients where Seri Scaffold is placed Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduction, Mastopexy No Implant, No Seri | Patients undergoing reduction or mastopexy but no implant is used and no Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Nipple to Fold Measurement on Stretch | The Nipple to fold will be measured manually over time to 1 year | Posted | Mean | Full Range | centimeters | 1 year post op |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduction, Mastopexy No Implant, No Seri | Patients undergoing reduction or mastopexy but no implant is used and no Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| seroma | Skin and subcutaneous tissue disorders | Systematic Assessment | seroma and partial Seri removal |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment | skin dehiscence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Bradley Bengtson | Bengtson Center | 616 588 8880 | drb@bengtsoncenter.com |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D001763 | Blepharoptosis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005141 | Eyelid Diseases |
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|
| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| Mastopexy, Implant no Seri Scaffold |
Mastopexy with implant, No Seri support is used Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| BG002 | Breast Reduction With Seri Support | Patients undergoing breast reduction with the use of Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| BG003 | Augmentation Mastopexy, Implant and Seri | Augmentation Mastopexy patients where Seri Scaffold is placed Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Breast Reduction With Seri Support | Patients undergoing breast reduction with the use of Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
| OG003 | Augmentation Mastopexy, Implant and Seri | Augmentation Mastopexy patients where Seri Scaffold is placed Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. |
|
|
| Secondary | Percent Breast Tissue Above Nipple | The percentage of breast tissue above and below the horizontal plane of the nipple over time | Posted | Mean | Full Range | percentage of volume | 1 year post op |
|
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Mastopexy, Implant no Seri Scaffold | Mastopexy with implant, No Seri support is used Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. | 0 | 25 | 2 | 25 |
| EG002 | Breast Reduction With Seri Support | Patients undergoing breast reduction with the use of Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. | 3 | 26 | 3 | 26 |
| EG003 | Augmentation Mastopexy, Implant and Seri | Augmentation Mastopexy patients where Seri Scaffold is placed Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. | 2 | 61 | 2 | 61 |
|
| dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment | skin dehiscence |
|
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Superficial infection limited to the skin |
|
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| D005128 | Eye Diseases |