An interventional study of REBUILD Bioabsorbable in Laparotomy, sponsored by AbSolutions Med Inc.. Status unknown at 2 sites in Colombia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-27.
Sponsored by AbSolutions Med Inc. · Not applicable, Interventional, and Treatment
The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.
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.
AbSolutions Med Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo oncologic laparotomy per the standard of care. The abdominal wall will be closed with REBUILD Bioabsorbable and suture of the surgeon's choice.
Device: REBUILD Bioabsorbable
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.
Adverse Events
The number of device-related adverse events
Time frame: 12 months
Performance
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.
Time frame: 12 months
Plan to share: No
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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AbSolutions Med Inc.