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| Name | Class |
|---|---|
| FGK Clinical Research GmbH | INDUSTRY |
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This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventrio Group | Patients diagnosed with a ventral hernia requiring an open surgery for repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bard Ventrio Hernia Patch | Device | The Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. | A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure. | 1 year post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with a diagnosis of ventral hernia will be screened for eligibility against the study protocol inclusion and exclusion criteria utilizing standard preoperative criteria (e.g. physical examination, blood work, medical evaluation, etc) which occurred within 30 days of the date of consent.
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| Name | Affiliation | Role |
|---|---|---|
| David Iannitti, MD, FACS | Carolinas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter Medical Group GNS | Sacramento | California | United States | |||
| Sacred Heart Health System, Inc. |
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From March 2009 through May 2010, a total of 119 patients were enrolled at 7 study centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ventrio Group | Patients diagnosed with a ventral hernia requiring an open surgery for repair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ventrio Group | Patients diagnosed with a ventral hernia requiring an open surgery for repair. |
| 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 | The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. | A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure. | All enrolled patients. | Posted | Number | participants | 1 year post surgery |
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Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
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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 | Ventrio Group | Patients diagnosed with a ventral hernia requiring an open surgery for repair. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Consitpation | Gastrointestinal disorders | MedDRA (12.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) |
This study was designed as a single arm observational trial without predefined statistical hypotheses (theories) to test; therefore, data can only be described and no treatment comparisons or conclusions can be made.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Heimer/Director, Clinical Affairs | C.R. Bard: Davol, Inc. | 401-825-8681 | dawn.heimer@crbard.com |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| From the time of surgery to hospital discharge, an average of 1-2 days |
| Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. | Hospital discharge through 21 days post surgery |
| Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. | 22 days post surgery through 1 year post surgery |
| Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Mean Quality of Life scores at each study visit for the "sensation of mesh," "pain," and "movement limitation" components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure. | Baseline and post-surgery at week 2, month 6 and month 12 |
| Procedure Time | Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed. | Day of surgery |
| Pensacola |
| Florida |
| 32504 |
| United States |
| RUSH Univeristy Medical Center | Chicago | Illinois | United States |
| Associated Surgical Group | Peoria | Illinois | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Gaston Memorial Hospital | Gastonia | North Carolina | 28054 | United States |
| Novant Clinical Research Institute | Winston-Salem | North Carolina | 27103 | United States |
| Death |
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| No longer wished to participate |
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| Unable to meet follow-up requirements |
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| Moved to area without study site |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
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| Secondary | Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. | All enrolled patients. | Posted | Number | Complication events | From the time of surgery to hospital discharge, an average of 1-2 days |
|
|
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| Secondary | Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. | All enrolled patients. | Posted | Number | Complication events | Hospital discharge through 21 days post surgery |
|
|
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| Secondary | Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. | All enrolled patients. | Posted | Number | Complication events | 22 days post surgery through 1 year post surgery |
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|
|
| Secondary | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Mean Quality of Life scores at each study visit for the "sensation of mesh," "pain," and "movement limitation" components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure. | All enrolled patients with QOL scores at each visit. | Posted | Mean | Standard Deviation | units on a scale (0-5) | Baseline and post-surgery at week 2, month 6 and month 12 |
|
|
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| Secondary | Procedure Time | Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed. | All enrolled patients. | Posted | Mean | Standard Deviation | minutes | Day of surgery |
|
|
|
| 8 |
| 119 |
| 14 |
| 119 |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (12.0) |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (12.0) |
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| Hepatic failure | Hepatobiliary disorders | MedDRA (12.0) |
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| Abdominal abscess | Infections and infestations | MedDRA (12.0) |
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| Postoperative wound infection | Infections and infestations | MedDRA (12.0) | Subject's study device removed as a result of postoperative wound infection and seroma. |
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| Wound infection | Infections and infestations | MedDRA (12.0) |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (12.0) |
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| Seroma | Injury, poisoning and procedural complications | MedDRA (12.0) | Subject's study device removed as a result of postoperative wound infection and seroma. |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) |
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| Bile duct cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA (12.0) |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA (12.0) |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (12.0) | Study device was removed approximately 6 months post procedure as a result of procedural pain. |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA (12.0) |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
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| Oesophagitis | Gastrointestinal disorders | MedDRA (12.0) |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.0) |
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| Application site vesicles | General disorders | MedDRA (12.0) |
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| Hernia | General disorders | MedDRA (12.0) | Patient developed a new (non-study) hernia at a different surgical site as the result of a non-study procedure. |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (12.0) | Two adverse events were identified by clinical monitoring but not reported in the clinical database by the study site (one event of postoperative ileus and one event of abdominal pain). |
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| Seroma | Injury, poisoning and procedural complications | MedDRA (12.0) |
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| Hypoaesthesia | Nervous system disorders | MedDRA (12.0) |
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| Urinary retention | Renal and urinary disorders | MedDRA (12.0) |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Haematoma | Vascular disorders | MedDRA (12.0) |
|
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| Title | Measurements |
|---|---|
|
| Pain: baseline |
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| Pain: week 2 |
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| Pain: month 6 |
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| Pain month 12 |
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| Movement limitations: baseline |
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| Movement limitations: week 2 |
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| Movement limitations: month 6 |
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| Movement limitation month 12 |
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