Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT04024956
Eligibility Criteria:
Inclusion Criteria:
Preoperative inclusion criteria:
Subjects will be eligible according the following criteria:
1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
2. Subjects who are ≥ 18 years old.
3. Subjects who are able to comply with the follow-up or other requirements.
4. 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 Criteria:
Preoperative exclusion criteria
Subjects who meet any of the following criteria will be excluded from participation:
1. Female subjects who are pregnant and/or breastfeeding.
2. 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)).
3. Subject with bleeding disorders requiring anti-coagulation medication (except acetylsalicylic acid).
4. Subjects who receive double-coagulation.
5. Subjects who receive peritoneal dialysis.
6. Subjects who previously required liver transplantation.
7. Subjects with a presence of systemic infection.
8. Subject who previously participated in this study, or in any investigational drug- or device study within 30 days of screening.
9. 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:
1. Subjects with multivisceral resections, except resection of spleen.
2. Not able to apply the patch(es) according to the Instructions For Use.
3. 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:
4. Subjects with a Grade 3 or 4 of bleeding after primary closure after liver transection (Lewis 2016).
5. Subjects with liver cirrhosis Grade C on the Child-Turcotte-Pugh score.
Additional for pancreas group:
6. Subjects with a margin of \< 1 cm between the defect and the portal vein.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04024956
Study Brief:
Protocol Section:
NCT04024956