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Hemopatch · 1 trial · 7 indications
Incidence of clinically-significant POPF - defined as ISGPS Grade B or C POPF. Determination of Grade B or C POPF was made on the basis of confirmation of presence of pancreatic fistula (any measurable volume of drain fluid on or after postoperative day 3, with an amylase content greater than 3 times the upper normal serum value) in conjunction with a review of participants' postoperative clinical course.
| Arm | Type | Description |
|---|---|---|
| Hemopatch | EXPERIMENTAL | Application of hemopatch to the divided end of the pancreas during surgery |
| Name | Type | Description |
|---|---|---|
| Hemopatch | DEVICE | Application of hemopatch to the divided end of the pancreas during surgery. |
Inclusion Criteria: * Scheduled to undergo distal pancreatectomy surgery that is open or laparoscopic, with or without splenectomy * Age ≥ 18 years * Able and willing to comply with study procedures and follow-up examinations contained within the written consent form Exclusion Criteria: * Contrai...
Hemopatch is a novel tissue sealant being studied for use in prolonged air leak after lung resection and for preventing post-operative pancreatic fistula following distal pancreatectomy in patients with pancreas cancer, pancreas disease, or pancreas adenocarcinoma.
Hemopatch is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX.
Hemopatch is in clinical development. One completed trial was a Phase 3 study for prolonged air leak after lung resection, and another completed trial was a Phase 2 study for preventing pancreatic fistula after distal pancreatectomy. It remains investigational.
Hemopatch has been studied in two completed trials. NCT02491671 was a Phase 3 study in Spain with 260 participants evaluating its effectiveness in preventing prolonged air leak after lung resection. NCT03410914 was a Phase 2 study in Canada with 52 participants for intra-operative application to the pancreatic stump.
Hemopatch is described as a novel tissue sealant in clinical trial documentation. It is applied during surgery to seal tissue and prevent complications such as air leaks or fluid leaks.