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Trial record 3 of 5 for:    polyganics

Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery (SHIELDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04024956
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : March 5, 2020
Sponsor:
Collaborator:
Genae
Information provided by (Responsible Party):
Polyganics BV

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 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.


Condition or disease Intervention/treatment Phase
Pancreatectomy Hepatic Resection Device: Sealing Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single-arm, multicenter study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Sealing Device
Sealing Device applied in hepatic resection or distal pancreatectomy
Device: Sealing Device
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: Day 1 ]
    Intra-operative control bleeding

  2. Leak-associated comorbidities [ Time Frame: 16 months ]
    Incidence of leak-associated comorbidities

  3. re-intervention [ Time Frame: 16 months ]
    Incidence of re-intervention

  4. Ease of Use [ Time Frame: Day 1 ]
    Ease of Use of the device as measured by questionnaire

  5. Post-operative bile leakage [ Time Frame: 90 and 180 days ]
    Incidence of post-operative bile leakage (liver only)

  6. Post-hepatectomy haemorrhage (PHH) [ Time Frame: 30 days ]
    Incidence of post-operative bleeding (liver only)

  7. Post-operative pancreatic juice leakage [ Time Frame: 90 and 180 days ]
    Incidence of post-operative pancreatic juice leakage (pancreas only)

  8. Post-pancreatectomy haemorrhage (PPH) [ Time Frame: 30 days ]
    Incidence of post-operative bleeding (pancreas only)

  9. (Serious) Adverse Device Effects [ Time Frame: 16 months ]
    Incidence of (Serious) Adverse Device Effects

  10. Incidence of transfusion [ Time Frame: 16 months ]
    Incidence of transfusion

  11. Length of hospital stay [ Time Frame: 30 days ]
    Length of hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024956


Contacts
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Contact: Hilde Geraedts, PhD +31 50 588 6582 h.geraedts@polyganics.com
Contact: Ester Maas-Soer, MSc +31 50 588 6582 e.maas-soer@polyganics.com

Sponsors and Collaborators
Polyganics BV
Genae

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Responsible Party: Polyganics BV
ClinicalTrials.gov Identifier: NCT04024956    
Other Study ID Numbers: CIP-3
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Polyganics BV:
Hepatic resection
Distal pancreatectomy
Sealant