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| Name | Class |
|---|---|
| Imarc Research, Inc. | INDUSTRY |
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Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiquiBand FIX8® OHMF Device | Experimental | Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiquiBand FIX8 Open Hernia Mesh Fixation Device | Device | Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device. Subjects will be evaluated intra-operatively, post-operatively, at discharge, and at 12 months post-operatively. The Liquiband surgical study device is considered a permanent implant. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the LiquiBand FIX8 OHMF device | Effectiveness will be defined as successful fixation of the hernia mesh (ie not requiring additional fixation by an alternate device) using the LiquiBand FIX8 device at the time of surgery. Based on data pooled from published studies of a similar device (which employs the same cyanoacrylate glue to fix hernia mesh, via a laparoscopic rather than open surgical approach), there has been an observed failure rate of 0.8% in mesh fixation. This study aims to demonstrate non-inferiority of the LiquiBand FIX8 device to a failure rate of 5% (medically acceptable inference). | Time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the LiquiBand FIX8 OHMF device | The incidence of adverse events (whether or not determined to be related to the LiquiBand FIX8 Device) will be recorded. Complications assessed during the study will include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis of wound closure using the Visual Analogue Scale | Cosmesis of the wound closure will be assessed by the investigator and patient, and measured by Visual Analogue Scale (0 = Very poor cosmetic outcome; to 10 = very good cosmetic outcome). | 12-months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Mihailescu, MD | Tameside & Glossop Integrated Care NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tameside General Hospital | Ashton-under-Lyne | United Kingdom | ||||
| James Paget University Hospitals NHS Foundation Trust |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 0 (intra-operatively), up to 2 days (discharge from hospital) and 12-months post surgery |
| Effectiveness of the LiquiBandFIX8 OHMF device for topical wound closure | Defined as successful closure of the incision site using the LiquiBand FIX8 Device (not requiring additional fixation by an alternate device). | Time of surgery |
| Assessment of chronic post-operative pain using the Visual Analogue Scale: the minimal clinically important difference and patient acceptable symptom state. | Chronic post-operative pain will be assessed using the following measures:
| 12-months post-surgery |
| Long term performance of the study device | Long-term performance will be assessed by rate of hernia recurrence. | 12-months post surgery |
| Comparison of cost-effectiveness of patients treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique. | A study-specific outcome model will be used, which will calculate an incremental cost effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) achieved with the introduction of the LiquiBand FIX8 OHMF device compared with using a standard surgical technique (suture fixation). | 12-months |
| Comparison of costs of patients' clinical events treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique. | A study-specific outcome model will be used which will calculate an incremental cost effectiveness ratio (ICER) given in terms of clinical events avoided achieved with the introduction of the LiquiBand FIX8 OHMF device compared with using a standard surgical technique (suture fixation). | 12-months |
| Clinician satisfaction | Users will be asked to rate the device on factors relating to ease of use and satisfaction, compared with their experience of other hernia mesh fixation devices. Satisfaction will be assessed using a Likert-type scale (e.g. Very satisfied (1), Satisfied (2), Neither (3), Dissatisfied (4), Very dissatisfied (5)) | 0 (Post Surgery) and upto 2 days (hospital discharge) |
| Great Yarmouth |
| NR31 6LA |
| United Kingdom |
| Wirral University Teaching Hospital NHS Foundation Trust | Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |