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A multi-center post-market single arm prospective study of Parieteneâ„¢ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)
A multi-center post-market single arm prospective study of Parieteneâ„¢ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)
125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parietene DS Composite Mesh | Experimental | Patients treated with Parietene DS Composite Mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parietene DS Composite Mesh | Device | All subjects enrolled will receive the Parietene DS Composite Mesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hernia Recurrence Within 12 Months Following Parieteneâ„¢ DS Composite Mesh Use in Ventral Hernia Repair | 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parieteneâ„¢ DS Composite Mesh Use in Ventral Hernia Repair. | operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery | |
| Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parieteneâ„¢ DS Composite Mesh Use in Ventral Hernia Repair |
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Inclusion Criteria:
Preoperative Inclusion Criteria
Exclusion Criteria:
Preoperative Exclusion Criteria
Intra-operative Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sue Kim | Medtronic - Surgical Innovations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady of the Lakes Regional Medical Center | Baton Rouge | Louisiana | 70808 | United States | ||
| University of Missouri - Columbia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parietene DS Composite Mesh | Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Post Market Study of Parieteneâ„¢ DS Composite Mesh in Ventral Hernia Repair
Approximately 125 Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Parietene DS Composite Mesh | Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite 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 Within 12 Months Following Parieteneâ„¢ DS Composite Mesh Use in Ventral Hernia Repair | Hernia recurrence rate at 12M changed from what was previously reported, 4 (3.5%) due to data imputed for hernia recurrence. It was assumed subjects who missed the 12M visit and had no recurrence at 24M also had no recurrence at 12M, as hernias cannot appear and then disappear over time without treatment. There were 5 subjects excluded from the primary endpoint analysis due to not completing the 12M/24M visits and therefore, unable to determine if a recurrence occurred in these subjects. | Posted | Count of Participants | Participants | 12 months post surgery |
|
Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative
Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
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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 | Parietene DS Composite Mesh | Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (25.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Injury, poisoning and procedural complications | MedDRA (25.0) | Non-systematic Assessment |
There were no limitations or caveats in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alyssa Sutch, Senior Clinical Research Specialist | Medtronic | 612-214-9756 | alyssa.m.sutch@medtronic.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 | Dec 3, 2021 | Jul 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2022 | Jul 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All subjects enrolled will receive the Parietene DS Composite Mesh
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| 1 month, 3 months, and 24 months post-surgery |
| Columbia |
| Missouri |
| 65201 |
| United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Hernia Center of Excellence LLC | Newport News | Virginia | 23606 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Death |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Unable to gather information from subject due to age and limited abilities |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Ethnicity | Count of Participants | Participants |
|
| Height, cm | Mean | Standard Deviation | centimeters |
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| Weight, kg | Mean | Standard Deviation | kilograms |
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| BMI, kg/m^2 | Mean | Standard Deviation | kg/m^2 |
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| Pregnancy Test Performed | [1] Measure Analysis Population Description: Pregnancy test was only performed for female subjects of child bearing age and potential. Pregnancy tests for women are request at the time of screening and operation except for women who are post-menopausal for at least 2 years or surgically sterile. If screening was done the same day of operation (as permitted by CIP), only one pregnancy test is necessary. | Count of Participants | Participants |
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| Secondary | Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parieteneâ„¢ DS Composite Mesh Use in Ventral Hernia Repair. | Posted | Number | number of participants with ADEs | operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery |
|
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|
|
| Secondary | Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parieteneâ„¢ DS Composite Mesh Use in Ventral Hernia Repair | The overall number of participants analyzed may vary at different follow-up time points due to some assessments not being completed, which are required for inclusion in the analysis. At Baseline and Procedure there were 125 patients treated; each follow-up visit was missing some of those treated patients. Pre-specified full analysis set was inclusive of patients that missed follow-up. Subjects were not considered lost to follow-up until the 24M follow-up period was completed. | Posted | Count of Participants | Participants | 1 month, 3 months, and 24 months post-surgery |
|
|
|
|
| 2 |
| 125 |
| 29 |
| 125 |
| 20 |
| 125 |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Ileus Paralytic | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Abdominal Wall Abscess | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Abscess | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| COVID-19 Pneumonia | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Procedural Nausea | Injury, poisoning and procedural complications | MedDRA (25.0) | Non-systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (25.0) | Non-systematic Assessment |
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| Hemoglobin Decreased | Investigations | MedDRA (25.0) | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Neuroendocrine Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Non-systematic Assessment |
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| Pancreatic Neuroendocrine Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Breast Necrosis | Reproductive system and breast disorders | MedDRA (25.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Pacemaker Generated Rhythm | Surgical and medical procedures | MedDRA (25.0) | Non-systematic Assessment |
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| Aortic Stenosis | Vascular disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Ileus | General disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Internal Hernia | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Oesophageal Stenosis | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Umbilical Hernia | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA (25.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Number of participants with incidence of ADEs within 3 Months |
|
| Number of participants with incidence of ADEs within 12 Months |
|
| Number of participants with incidence of ADEs within 24 Months |
|
| Number of Subjects with ADEs |
| 31 |
| 2-Sided |
| Other |
Statistical Analysis is based on number of participants with incidence of ADEs within 1 month. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs. |
| Number of Subjects with ADEs | 34 | 2-Sided | Other | Statistical Analysis is based on number of participants with incidence of ADEs within 3 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs. |
| Number of Subjects with ADEs | 40 | 2-Sided | Other | Statistical Analysis is based on number of participants with incidence of ADEs within 12 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs. |
| Number of Subjects with ADEs | 42 | 2-Sided | Other | Statistical Analysis is based on number of participants with incidence of ADEs within 24 months. Adverse Device Effects (ADEs) are inclusive of both procedure and device related AEs. |
|
| Participants with hernia recurrence within 24 months |
|
|
| % of Subjects with Recurrence within 3M |
| 0 |
| 2-Sided |
| 95 |
| 0 |
| 3.0 |
| Other |
This was not a comparative endpoint. |
| % of Subjects with Recurrence within 24M | 4 | 2-Sided | 95 | 1.2 | 9.6 | Other | This was not a comparative endpoint. |