A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating the Safety and Performance of GATT-Patch for Hemostasis during Open Liver Surgery
- Conditions
- hemostasisuncontrolled bleeding10019818
- Registration Number
- NL-OMON50906
- Lead Sponsor
- GATT Technologies BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 47
* 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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method