Status:
COMPLETED
Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery
Lead Sponsor:
Polyganics BV
Collaborating Sponsors:
Genae
Conditions:
Pancreatectomy
Hepatic Resection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Preoperative inclusion criteria:
- Subjects will be eligible according the following criteria:
- Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
- Subjects who are ≥ 18 years old.
- Subjects who are able to comply with the follow-up or other requirements.
- Subjects who are planned for an elective hepatic resection or distal pancreatectomy.
- During the surgery, the patients also need to comply with the intraoperative criteria.
- Intraoperative inclusion criteria:
- Subjects will be eligible according the following criteria:
- 1\. Patch is applied manually (during open procedure, conversion procedure, or laparoscopic assisted procedure).
Exclusion
- Preoperative exclusion criteria
- Subjects who meet any of the following criteria will be excluded from participation:
- Female subjects who are pregnant and/or breastfeeding.
- Subjects with a known allergy to any of the components of the Sealing Device (Polyurethane (SDPU), 8-ArmPEG40k-SC (SDA), Disodium Hydrogen Phosphate (Na2HPO4) (BS) and DC-Green #6 (SDD)).
- Subject with bleeding disorders requiring anti-coagulation medication (except acetylsalicylic acid).
- Subjects who receive double-coagulation.
- Subjects who receive peritoneal dialysis.
- Subjects who previously required liver transplantation.
- Subjects with a presence of systemic infection.
- Subject who previously participated in this study, or in any investigational drug- or device study within 30 days of screening.
- Subjects undergoing a procedure requiring an anastomosis (e.g. Klatskin tumours or Whipple).
- Intraoperative exclusion criteria:
- Subjects who meet any of the following criteria will be excluded from participation:
- Subjects with multivisceral resections, except resection of spleen.
- Not able to apply the patch(es) according to the Instructions For Use.
- Total surgery requiring \> 3 HPB Sealing Devices of 10 x 5 cm (which equals a resection surface of more than 88cm2).
- Additional for liver group:
- Subjects with a Grade 3 or 4 of bleeding after primary closure after liver transection (Lewis 2016).
- Subjects with liver cirrhosis Grade C on the Child-Turcotte-Pugh score.
- Additional for pancreas group:
- Subjects with a margin of \< 1 cm between the defect and the portal vein.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04024956
Start Date
August 25 2020
End Date
May 26 2023
Last Update
July 3 2023
Active Locations (2)
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1
Universitats Klinikum Hamburg-Eppendorf
Hamburg, Germany
2
University Hospital Oldenburg
Oldenburg, Germany