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| Name | Class |
|---|---|
| Cogent Technologies Corporation | UNKNOWN |
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The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy. The main question it aims to answer are whether the device when used to support suture in abdominal wall closure safely maintains apposition of the abdominis rectus muscles within a pre-defined distance.
Participants will undergo standard of care laparotomy and the investigational device will be used to support the suture used to close the abdominal wall. Participants will have an MRI at 1-month after surgery to measure the distance between the abdominus rectus muscles.
The REBUILD Trial (Protocol CTP-0002) is an investigational medical device study designed to demonstrate the efficacy and safety of REBUILD for abdominal wall closure (AWC). The primary evaluation period will include the first 30 days of follow up. After the 1-month endpoint evaluation period, additional follow-up at 3, 6, 12, and 24-months for post-market analysis and publication will be conducted. All adverse events will be collected and reported for the full duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REBUILD | Experimental | REBUILD is an investigational medical device (bioabsorbable anchor and deployment instruments) used with third party suture to close the abdominal wall. As the suture and Anchor absorb, abdominal wall forces gradually transfer to the organizing scar, one of the tenets of successful wound tensile strength acquisition. After full absorption, no permanent material remains that would otherwise alter normal anatomy, anisotropic properties, or compliance of the abdominal wall (Deeken, 2017). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REBUILD | Device | 3.1.1. REBUILD is an investigational medical device provided as a sterile, single use set containing 10 suture Anchors and two non-implantable Carriers, with reusable stainless-steel instruments for deployment supplied separately. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Measure distance between the rectus abdominus muscles | The primary efficacy endpoint is a maximum distance between the RAMs at 1-month after surgery < 2.5 cm (binary outcome). | Day 30 (+14/-7 days) |
| Serious device related adverse events | The primary safety endpoint is serious device-related adverse events through 1-month follow-up. | Day 30 (+14/-7 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Jacobs, MD | Contact | 650-303-6140 | djacobs@absolutionsmed.com | |
| Kathryn Kelley, RN, BSN | Contact | 925-360-5173 | kkelley@absolutionsmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The scientific rationale for a single-arm study is based on existing data and experience associated with current approaches for managing abdominal closure. Suture techniques and mesh have been extensively studied (Deerenberg EB, 2015) (Jairam, 2017) and several clinical publications serve as historical precedents for the 1-month endpoint (Table 2). The results of this REBUILD Study will thus exist in a broad context of outcomes, allowing significant comparisons in the absence of a concomitant control group.
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