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This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SeriScaffold® Surgical Scaffold | Experimental | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeriScaffold® Surgical Scaffold | Device | A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | Month 3, Month 12, Month 18, Month 24 |
| Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Düsseldorf | Germany | |||||
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Enrollment was defined as having signed the IRB-approved Informed Consent Form. 104 participants were enrolled, of which 100 were implanted with SERI® Surgical Scaffold and are presented in the participant flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | SeriScaffold® Surgical Scaffold | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use. |
| Immediately Following Stage 1 Surgery |
| Breast Anatomy Measurements | Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold. | Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24 |
| Subject Satisfaction With Breasts on a 5-Point Scale | Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied. | Baseline, Month 6, Month 12, Month 18, Month 24 |
| Munich |
| Germany |
| Milan | Italy |
| Barcelona | Spain |
| Nottingham | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Subjects implanted with SERI® during their Stage I breast reconstruction surgery
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| ID | Title | Description |
|---|---|---|
| BG000 | SeriScaffold® Surgical Scaffold | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | All participants with a Month 6 visit. 12 subjects exited the study prior to Month 6. | Posted | Mean | Standard Deviation | Scores on a Scale | Month 6 |
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| Secondary | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | All participants with a visit at the designated time point | Posted | Mean | Standard Deviation | Scores on a Scale | Month 3, Month 12, Month 18, Month 24 |
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| Secondary | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use. | All implanted participants. "Scaffold cutting and sharping before implantation" was reported "Not done" on n=50 | Posted | Number | Participants | Immediately Following Stage 1 Surgery |
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| Secondary | Breast Anatomy Measurements | Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold. | All implanted breasts evaluated at the designated time point | Posted | Mean | 95% Confidence Interval | Centimeters (cm) | Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24 | Breasts | Breasts |
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| Secondary | Subject Satisfaction With Breasts on a 5-Point Scale | Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied. | All implanted breasts evaluated at the designated time point. Data was not available for 1 subject (both breasts) at baseline, 1 subject (right breast) at Month 6, 2 subjects (right breast) at Month 18 and 1 subject (right breast) at Month 24. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6, Month 12, Month 18, Month 24 | Breasts | Breasts |
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Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
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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 | SeriScaffold® Surgical Scaffold | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. | 53 | 100 | 92 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Capsular contracture associated with breast implant | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Device extrusion | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA version 18.0 | Non-systematic Assessment |
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| Physical examination abnormal | Investigations | MedDRA version 18.0 | Systematic Assessment |
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| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
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| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Device Dislocation | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Medical Device Complication | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Device Related Infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Endometritis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Staphylococcal Infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Fractured Sacrum | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
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| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
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| Benign Breast Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
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| intraductal Proliferative Breast Lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
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| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
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| Metastases to Spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 18.0 | Systematic Assessment |
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| Placenta Previa | Pregnancy, puerperium and perinatal conditions | MedDRA version 18.0 | Systematic Assessment |
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| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment |
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| Ovarian Cyst | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment |
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| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Skin Atrophy | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Capsular contracture associated with breast implant | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Device dislocation | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Device extrusion | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Impaired healing | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Implant site reaction | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA version 18.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 18.0 | Non-systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA version 18.0 | Non-systematic Assessment |
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| Physical examination abnormal | Investigations | MedDRA version 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 18.0 | Non-systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
| OG004 | Ease of Use During Surgery = Very Easy to Use | Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
| OG005 | Not Done | Implanted participants on whom procedure was reported "not done" |
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Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
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