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

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ClinicalTrials.gov Identifier: NCT04024956
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
Genae
Information provided by (Responsible Party):
Polyganics BV

Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE August 25, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Bile leakage [ Time Frame: 30 days ]
    Incidence of post-operative bile leakage (International Study Group of Liver Surgery Bile leakage Grading Scale)
  • Pancreatic leakage [ Time Frame: 30 days ]
    Incidence of post-operative pancreatic juice leakage (International Study Group of Pancreas Surgery Grading Scale)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Bleeding [ Time Frame: Day 1 ]
    Intra-operative control bleeding
  • Leak-associated comorbidities [ Time Frame: 16 months ]
    Incidence of leak-associated comorbidities
  • re-intervention [ Time Frame: 16 months ]
    Incidence of re-intervention
  • Ease of Use [ Time Frame: Day 1 ]
    Ease of Use of the device as measured by questionnaire
  • Post-operative bile leakage [ Time Frame: 90 and 180 days ]
    Incidence of post-operative bile leakage (liver only)
  • Post-hepatectomy haemorrhage (PHH) [ Time Frame: 30 days ]
    Incidence of post-operative bleeding (liver only)
  • Post-operative pancreatic juice leakage [ Time Frame: 90 and 180 days ]
    Incidence of post-operative pancreatic juice leakage (pancreas only)
  • Post-pancreatectomy haemorrhage (PPH) [ Time Frame: 30 days ]
    Incidence of post-operative bleeding (pancreas only)
  • (Serious) Adverse Device Effects [ Time Frame: 16 months ]
    Incidence of (Serious) Adverse Device Effects
  • Incidence of transfusion [ Time Frame: 16 months ]
    Incidence of transfusion
  • Length of hospital stay [ Time Frame: 30 days ]
    Length of hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery
Official Title  ICMJE Prospective, Multicenter Study to Evaluate the Safety and Performance of a syntHetic Tissue Sealant in Reducing fluId lEakage Following Elective hepatobiLiary anD Pancreatic Surgery
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label, single-arm, multicenter study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatectomy
  • Hepatic Resection
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Sealing Device
Sealing Device applied in hepatic resection or distal pancreatectomy
Intervention: Device: Sealing Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04024956
Other Study ID Numbers  ICMJE CIP-3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Polyganics BV
Study Sponsor  ICMJE Polyganics BV
Collaborators  ICMJE Genae
Investigators  ICMJE Not Provided
PRS Account Polyganics BV
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP