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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 an investigational surgical 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 and other pancreas diseases. It is developed by Baxter International Inc. and is currently in clinical development.
Hemopatch is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX. The company is conducting clinical trials to evaluate the sealant's effectiveness in surgical settings.
Hemopatch is in Phase 2 clinical development. One Phase 2 trial has been completed, and a Phase 3 trial has also been completed. The drug is investigational and has not been reported as FDA approved.
Hemopatch has been studied in two completed trials. NCT02491671 was a Phase 3 trial in Spain with 260 participants evaluating the sealant for preventing prolonged air leak after lung resection. NCT03410914 was a Phase 2 trial in Canada with 52 participants studying its use on the pancreatic stump after distal pancreatectomy.
Hemopatch is described as a novel tissue sealant in clinical trials. It is being evaluated for its effectiveness in preventing prolonged air leak after lung resection and for preventing post-operative pancreatic fistula. No other alternative names for Hemopatch have been reported.