Polyganics BV (Groningen, The Netherlands), in close collaboration with University Hospital-Eppendorf (UKE) Hamburg, has developed the Sealing Device for use in hepato-pancreato-bilary (HPB) surgery to reduce leakage of fluids from the site of surgery into the abdominal cavity and as an adjunctive hemostatic device to control minimal to moderate bleeding at the surgical site. The Sealing Device has been challenged in pre-clinical testing (laboratory and in-vivo work), but has not been evaluated for safety and performance in humans. This investigation will be conducted to clinically assess the safety and performance of Sealing Device as a means to reduce bile and pancreatic juice leakage in hepato-pancreato-bilary (HPB) surgery. Secondarily, the control of minimal to moderate bleeding will be assessed. To achieve adequate representation of the primary objective, the study will contain two separate surgical patient groups: Liver and Pancreas. The primary objective of the study is to demonstrate safety and performance in reducing intra- and post-operative leakage (bile and pancreatic juices) by using the Sealing Device in patients undergoing elective hepatic resection or distal pancreatectomy. The study will be conducted as an open-label, single-arm, multicenter study with a 16 months follow up. Up to 80 patients (40 liver and 40 pancreas patients) will be enrolled at up to 7 sites in Europe.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The Sealing Device is indicated for use in hepato-pancreato-biliary (HPB) surgery to reduce leakage of fluids from the site of surgery into the abdominal cavity and as an adjunctive hemostatic device to control minimal to moderate bleeding at the surgical site.
Universitats Klinikum Hamburg-Eppendorf
Hamburg, Germany
University Hospital Oldenburg
Oldenburg, Germany
Bile leakage
Incidence of post-operative bile leakage (International Study Group of Liver Surgery Bile leakage Grading Scale); categories in order of ascending severity: biochemical leak, Grade B or Grade C
Time frame: 30 days
Pancreatic leakage
Incidence of post-operative pancreatic juice leakage (International Study Group of Pancreas Surgery Grading Scale); categories in order of ascending severity: biochemical leak, Grade B or Grade C
Time frame: 30 days
Bleeding
Intra-operative control bleeding
Time frame: Day 1
Leak-associated comorbidities
Incidence of leak-associated comorbidities
Time frame: 16 months
re-intervention
Incidence of re-intervention
Time frame: 16 months
Ease of Use
Ease of Use of the device as measured by questionnaire
Time frame: Day 1
Post-operative bile leakage
Incidence of post-operative bile leakage (liver only)
Time frame: 90 and 180 days
Post-hepatectomy haemorrhage (PHH)
Incidence of post-operative bleeding (liver only)
Time frame: 30 days
Post-operative pancreatic juice leakage
Incidence of post-operative pancreatic juice leakage (pancreas only)
Time frame: 90 and 180 days
Post-pancreatectomy haemorrhage (PPH)
Incidence of post-operative bleeding (pancreas only)
Time frame: 30 days
(Serious) Adverse Device Effects
Incidence of (Serious) Adverse Device Effects
Time frame: 16 months
Incidence of transfusion
Incidence of transfusion
Time frame: 16 months
Length of hospital stay
Length of hospital stay
Time frame: 30 days
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