Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03410914 | Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy | PHASE2 | COMPLETED | 52 | — | — | Aug 13, 2018 | Oct 23, 2020 | Nov 3, 2021 | 7 | Canada |
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...