To primary objective is to evaluate the clinical safety and performance of GATT-Patch in open liver surgery, in order to collect the necessary data to assess whether GATT-Patch meets the general safety and performance requirements for its CE marking…
ID
Source
Brief title
Condition
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary performance endpoint
The primary performance endpoint is defined by the percentage of cases
achieving hemostasis at 3 minutes.
Hemostasis will be defined by a grade of 0 (None/Dry) on the SPOT GRADE*, also
known as the Surface Bleeding Severity Score (SBSS). The SPOT GRADE provides a
validated score for assessment of bleeding at the target site, and consists of
6 subscales (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe; not immediately
life-threatening, 5=extreme; immediately life threatening) (Spotniz, 2017).
Investigators will be trained on the assessment scale prior to the
investigation to have consistent assessment of bleeding at the target site.
Achievement of hemostasis will be verified every 30 seconds. If hemostasis has
not been achieved prior to site closure (SPOT GRADE 1-5), then treatment is
considered a failure and additional hemostatic agents or techniques may be
used.
Safety objective and safety endpoints
The safety of GATT-Patch will be assessed by the nature, severity and incidence
of device-related adverse events. The adverse events found for GATT-Patch will
be compared to the current knowledge and state of the art to assess whether the
device is associated with acceptable safety outcomes.
Adverse events may include: mortality, thromboembolic event, re-intervention,
recurrent bleeding, biloma, blood transfusion, hematoma, surgical site
infection, fever/pyrexia, allergic reaction, incapsulated device on ultrasound
imaging.
Secondary outcome
Secondary performance endpoints
* Mean time to hemostasis (seconds)
* Percentage of hemostasis at 30, 60, 90, 120 and 150 seconds
No formal hypothesis testing will be performed for the secondary objectives and
endpoints of this clinical investigation.
Exploratory endpoints
In addition to the primary endpoint, the following exploratory endpoints will
be recorded: surgery time (minutes), blood loss (mL) during surgery, blood
Transfusion (mL) during hospitalization, SPOT GRADE (0-5) at the Target
Bleeding Site (TBS), use of adjunct hemostatic agents/techniques (e.g. cautery,
sutures or staples), amount of material needed versus bleeding surfaces, user
satisfaction (questionnaire).
Background summary
Hepatic surgery, such as liver resection, has been associated with considerable
mortality and morbidity. The postoperative mortality for major hepatectomy has
been reported in a range from 0.7-2.6%. The short-term and long-term outcomes
of open liver surgery may be influenced by uncontrolled bleeding during the
operation, and a need for blood transfusion. A 2011 retrospective analysis of
approximately 1.6 million surgeries, including cardiac, vascular, solid organ,
and spinal surgeries, found that the rate of bleeding-related complications was
29.9%, with blood transfusions occurring in 21.2% of all patients. There are
significant benefits to patients when hemostasis is addressed efficiently, and
effective treatment of bleeding may reduce blood loss and perioperative
complications.
During liver surgery, most luminal structures greater than 2mm in diameter are
controlled during parenchymal transection by temporary occlusion of inflow
vessels (e.g., Pringle maneuver to control inflow of the portal triad), and
control of bleeding from outflow vessels (lowering central venous pressure or
anterior elevation of the liver to avoid back-bleeding). After transection,
small volume bleeding may occur from the cut surface of the future liver
remnant. Ligation, or electrocautery techniques can be used to control bleeding
from visible compromised vessels. Bleeding from generalized venous ooze are
better controlled with topical hemostatic agents.
There is a wide variety of topical hemostatic devices, sealants and adhesives
available on the market and these can generally be divided into products
without active components, products that include active components that mimic
natural coagulation and combined agents. Recently, there has been an increase
in development of advanced hemostatic pads and patches that can provide
hemostasis and sealant properties similar to fibrin sealants (e.g., TachoSil).
GATT Technologies BV developed a novel hemostatic patch that consists of a
gelatin carrier and two synthetic activated polymers (NHS-POx) and is
considered a carrier-bound fibrin sealant. GATT-Patch has been developed to
provide a fast and robust control of bleeding during surgery. The current
investigation will be the first-in-human study that will evaluate the safety
and the performance of GATT-Patch in elective open liver surgery.
Study objective
To primary objective is to evaluate the clinical safety and performance of
GATT-Patch in open liver surgery, in order to collect the necessary data to
assess whether GATT-Patch meets the general safety and performance requirements
for its CE marking in Europe.
Study design
This is a pre-market, prospective, single arm, multicenter first-in-human
clinical investigation.
The clinical investigation will be split into 2 stages:
* Stage I of the clinical investigation will enroll a small cohort of subjects
within which the initial safety of GATT-Patch will be evaluated. A maximum of
12 subjects (25% of the overall population) will be treated , after which the
enrollment into the clinical investigation will be paused. A DMC will review
safety in this subset of subjects and decides whether the study may proceed.
* Stage II of the clinical investigation will enroll subjects until a total of
51 subjects have been treated with the investigational device.
In both Stage I and Stage II, subjects will follow the same clinical
investigation pathway. Stage I subjects will be analyzed for safety only,
whereas Stage II subjects will be analyzed for both safety and performance.
Intervention
GATT-Patch is a resorbable hemostatic sealing patch, contained in a sterile
blister pack within a pouch, for topical use in internal surgery. It does not
require any special storage requirements. It presents as a blue, soft,
flexible, gelatin fiber-based carrier impregnated with active polymers. Both
sides of the GATT-Patch are active and the material is suited to being torn
into smaller pieces for application in irregularly shaped structures and areas
that are difficult to access with a larger item. GATT-Patch will be applied
onto the wound site where the flexible and resorbable gelatin patch via contact
activation starts the coagulation cascade. The patch adheres to the tissue and
forms a seal across the damaged tissue, in order to ensure potential high
efficacy hemostasis.
Study burden and risks
The risks that are anticipated for participation in the clinical investigation
are:
* Anticipated adverse device effect for the use of GATT-Patch as provided in
Section 4.2.
* Procedure-related adverse events during liver surgery similar to the standard
of care.
CIP V03 Section 4.2
Results of the use risk assessment, the following risks are judged as
*tolerable and improbable to occur*, as *tolerable and remote to occur*, or
*tolerable and occasional to occur*.
* Toxic response
* Thromboembolic event
* (Re)Bleeding
* Allergic reaction
* Pain
* New surgery
* Infection
* Blockage of artery or vein / ischemia of organs
* Damage of organs and vessels
* Pulsatile hematoma
* Closing of intestinal track
* Biloma
Furthermore, the risk for encapsulated or rolled-up device was identified
during the risk management, at a lower risk level/incidence. This risk will be
further investigated in this clinical investigation by means of the 6-weeks
follow-up imaging.
There were no risks identified as *probable* or *frequent* to occur, neither at
a *not acceptable* risk level.
The intended clinical benefit of GATT-Patch is to provide fast and persistent
hemostasis during surgeries on internal organs, primarily parenchymatous organs
such as liver, spleen or kidney; or in other abdominal surgeries. It is
hypothesized that a high rate of fast and persistent hemostasis may result in
less clinical risk of complications to patients undergoing these surgeries.
Transistorweg 5
Nijmegen 6534 AT
NL
Transistorweg 5
Nijmegen 6534 AT
NL
Listed location countries
Age
Inclusion criteria
* Subject is scheduled to undergo an elective open surgery on the liver;
* Subject is willing and able to give written informed consent for
investigation participation;
* Subject is 18 years of age or older at the time of enrollment;
* Subject has been informed of the nature of the clinical investigation.
A subject must meet all of the following intra-operative inclusion criteria to
be enrolled into the investigation:
* Subject in whom the Investigator is able to identify a target bleeding site
at the liver resection plane for which any applicable conventional means for
hemostasis (e.g. suture, ligature or cautery) are ineffective or impractical
and the choice is made to use a topical hemostat for control of hemostasis;
* Subject has a target bleeding site with a SPOT GRADE of 1, 2, or 3
Exclusion criteria
A subject must not meet any of the following pre-operative exclusion criteria
to be enrolled into the clinical investigation:
* Subject is scheduled to undergo surgery on other organs besides the liver
(e.g. pancreas, colon, lungs);
* Subject is taking multiple antithrombotic therapies in therapeutic dosage up
to the time of surgery, (allowing exclusive use of acetylsalicylic acid);.
* Subject has platelet count <100 x 109/L, an activates partial thrombin time
of >100s, or international normalized ratio >2.5;.
* Subject is pregnant, planning on becoming pregnant or actively breast-feeding
during the follow-up period;
* Subject has a known hypersensitivity to brilliant blue (FD&C Blue #1);
* Subject has an active or suspected infection at the surgical site;
* Subject has a total bilirubin level of * 2.5 mg/dl
* Subject has had or has planned to receive any organ transplantation;
* Subject has American Association of Anesthesiologists (ASA) classification of
5;
* Subject has a life expectancy of less than 3 months;
* Subject has a documented severe congenital or acquired immunodeficiency;
* Subject in whom the investigational device will be used at the site of a
synthetic graft or patch implant;
* Subject is currently participating or has participated in another clinical
investigation within the past 30 days and is receiving/has received an
investigational drug, device, or biologic agent;
* Subject is not appropriate for inclusion in the clinical investigation, per
the medical opinion of the Investigator;
* Subject has any incidental (pre- and peri-operative) findings deemed by the
Investigator to potentially jeopardize the safety or welfare of the patient.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnumberinprogress |
| CCMO | NL76084.091.20 |