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Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
Pilot Study of patients across all wound classes for recurrence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resorbable Mesh | Other | Phasix Mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resorbable Mesh | Device | Phasix Mesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hernia Recurrence | A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence. | 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device Related Adverse Events | In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuri Novitsky, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Hernia Center | Beverly Hills | California | 90210 | United States | ||
| Cedars-Sinai Medical Center |
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Of 33 subjects enrolled, 8 were not treated with the study device: a contraindication to the placement of mesh was present in 4 subjects; complete removal of existing mesh from a prior hernia repair (in the same affected area) was not possible in 3 subjects; and 1 subject had an active or latent systemic infection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Resorbable Mesh | Phasix Mesh Resorbable Mesh: Phasix Mesh |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Resorbable Mesh | Phasix Mesh Resorbable Mesh: Phasix Mesh |
| 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 | Number of Participants With Hernia Recurrence | A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence. | Posted | Count of Participants | Participants | 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months |
|
|
Up to 24 months post index procedure
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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 | Resorbable Mesh | Phasix Mesh Resorbable Mesh: Phasix Mesh | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial surgical site infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Heimer | BD Interventional - Surgery | 401-825-8681 | Dawn.Heimer@crbard.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 21, 2014 | Feb 26, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2017 | Feb 26, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24 Months |
| Carolinas Comfort Scale (CCS) Total Score - Change From Baseline | The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline. | Baseline and 24 months postoperative |
| Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline) | Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline. | Baseline and 24 months postoperative |
| Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline) | Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline. | Baseline and 24 months postoperative |
| Surgical Procedure Time | Measured from incision to closure (skin to skin). | Duration of index procedure (mean of 242.5 mins) |
| Length of Hospital Stay | Measured from end of index procedure to hospital discharge | 10 Months |
| Number of Study Related Post Operative Surgical Procedures | 24 Months |
| Number of Study Related Post Operative New Hospital Admissions | 24 Months |
| Number of Related Post-operative Visits Unrelated to Standard of Care | 24 Months |
| Incidence of Seroma | 24 Months |
| Los Angeles |
| California |
| 90048 |
| United States |
| Florida Hospital Celebration Health | Celebration | Florida | 34747 | United States |
| Methodist Physicians Clinic | Omaha | Nebraska | 68114 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Secondary | Number of Participants With Device Related Adverse Events | In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| Secondary | Carolinas Comfort Scale (CCS) Total Score - Change From Baseline | The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline. | All participants with non-missing values at both baseline and respective post procedure assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months postoperative |
|
|
|
| Secondary | Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline) | Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline. | All participants with non-missing values at both baseline and respective post procedure assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months postoperative |
|
|
|
| Secondary | Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline) | Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline. | All participants with non-missing values at both baseline and respective post procedure assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months postoperative |
|
|
|
| Secondary | Surgical Procedure Time | Measured from incision to closure (skin to skin). | Posted | Mean | Standard Deviation | minutes | Duration of index procedure (mean of 242.5 mins) |
|
|
|
| Secondary | Length of Hospital Stay | Measured from end of index procedure to hospital discharge | Posted | Mean | Standard Deviation | days | 10 Months |
|
|
|
| Secondary | Number of Study Related Post Operative Surgical Procedures | Posted | Number | events | 24 Months |
|
|
|
| Secondary | Number of Study Related Post Operative New Hospital Admissions | Posted | Number | events | 24 Months |
|
|
|
| Secondary | Number of Related Post-operative Visits Unrelated to Standard of Care | Posted | Number | events | 24 Months |
|
|
|
| Secondary | Incidence of Seroma | Posted | Number | events | 24 Months |
|
|
|
| 25 |
| 6 |
| 25 |
| 6 |
| 25 |
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Seroma | General disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Stomal hernia | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Myocardial hypoxia | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Abdominal wall wound infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |