PancreatectomySHIELDSNCT04024956
Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery
A study testing Sealing Device in people with Pancreatectomy and Hepatic Resection, run by Polyganics BV at 2 sites in Germany.
Trial 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 to reduce leakage of fluids from the site of surgery into the abdominal cavity and as an adjunctive hemostatic device to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatectomy, Hepatic Resection
- What is being tested?
- Sealing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Aug 2020to 26 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitats Klinikum Hamburg-Eppendorf
Hamburg
University Hospital Oldenburg
Oldenburg
About this study
Official title: Prospective, Multicenter Study to Evaluate the Safety and Performance of a syntHetic Tissue Sealant in Reducing fluId lEakage Following Elective hepatobiLiary anD Pancreatic Surgery
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.
Read more
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.
- Conditions
- Pancreatectomy, Hepatic Resection
- Being tested
- Sealing Device
- Keywords
- Hepatic resection, Distal pancreatectomy, Sealant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sealing DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sealing Device | Experimental | Sealing Device applied in hepatic resection or distal pancreatectomy Receives: Device: Sealing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days
Secondary outcomes (11)
Bleeding
Intra-operative control bleeding
Measured: Day 1
Leak-associated comorbidities
Incidence of leak-associated comorbidities
Measured: 16 months
re-intervention
Incidence of re-intervention
Measured: 16 months
Ease of Use
Ease of Use of the device as measured by questionnaire
Measured: Day 1
Post-operative bile leakage
Incidence of post-operative bile leakage (liver only)
Measured: 90 and 180 days
Post-hepatectomy haemorrhage (PHH)
Incidence of post-operative bleeding (liver only)
Measured: 30 days
Post-operative pancreatic juice leakage
Incidence of post-operative pancreatic juice leakage (pancreas only)
Measured: 90 and 180 days
Post-pancreatectomy haemorrhage (PPH)
Incidence of post-operative bleeding (pancreas only)
Measured: 30 days
(Serious) Adverse Device Effects
Incidence of (Serious) Adverse Device Effects
Measured: 16 months
Incidence of transfusion
Incidence of transfusion
Measured: 16 months
Length of hospital stay
Length of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start25 Aug 2020
- Primary completion19 Nov 2021
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-arm, multicenter study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyganics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genae
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024956
- Sponsor's protocol ID
- CIP-3
- Acronym
- SHIELDS
- Status last verified
- Jun 2023
- First submitted
- 16 Jul 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study to Evaluate the Safety and Performance of a syntHetic Tissue Sealant in Reducing fluId lEakage Following Elective hepatobiLiary anD Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT04024956
- Acronym / sponsor ID
- SHIELDS / CIP-3
- Conditions
- Pancreatectomy, Hepatic Resection
- Keywords
- Hepatic resection, Distal pancreatectomy, Sealant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Polyganics BVIndustry (pharma, biotech, devices)
- Collaborators
- Genae
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-arm, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Sealing Device | Experimental | Device: Sealing DeviceSealing Device applied in hepatic resection or distal pancreatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- Preoperative exclusion criteria
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sealing DeviceThe 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. | Device | Sealing Device |
Primary outcome
Bile leakage
Time frame: 30 days
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
Pancreatic leakage
Time frame: 30 days
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
11 secondary outcomes
Bleeding
Time frame: Day 1
Leak-associated comorbidities
Time frame: 16 months
re-intervention
Time frame: 16 months
Ease of Use
Time frame: Day 1
Post-operative bile leakage
Time frame: 90 and 180 days
Post-hepatectomy haemorrhage (PHH)
Time frame: 30 days
Post-operative pancreatic juice leakage
Time frame: 90 and 180 days
Post-pancreatectomy haemorrhage (PPH)
Time frame: 30 days
(Serious) Adverse Device Effects
Time frame: 16 months
Incidence of transfusion
Time frame: 16 months
Length of hospital stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sealing Device in people with Pancreatectomy and Hepatic Resection, run by Polyganics BV at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bile leakage (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.