Laparotomy
Conditions
Keywords
Laparotomy, Abdominal Wall Closure
Brief summary
The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.
Detailed description
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall.
Interventions
DEVICEREBUILD Bioabsorbable
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.
Sponsors
Cogent Technologies Corporation
AbSolutions Med Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, single-arm, feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is 18-75 years of age 2. Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy 3. Patient is able to provide written informed consent 4. Patient is able and willing to comply with all study requirements
Exclusion criteria
1. Patient is scheduled for a palliative procedure 2. Patient has had previous failed surgical repair of a ventral or incisional hernia 3. Patient has a current infection at the intended surgical site 4. Patient is participating in a concurrent investigational medical device study 5. Patient is pregnant or planning on becoming pregnant during the study period 6. Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 months | The number of device-related adverse events |
| Performance | 12 months | The number of subjects with abdominal wall integrity at 3-, 6-, and 12-months post-surgery. Abdominal wall integrity will be assessed via clinical examination of the abdomen to identify a fascial defect, bulge, reducible palpable mass, or discomfort with a cough impulse. Standard of care CT or MR imaging that is performed within 12 months of the surgery will be evaluated to confirm apposition of the medial border of the rectus abdominis muscles and integrity of the abdominal wall. |
Countries
Colombia
Contacts
Primary ContactDaniel Jacobs, MD
Backup ContactKathryn Kelley, BSN
Outcome results
None listed