NL-OMON50906CompletedNot Applicable
A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating the Safety and Performance of GATT-Patch for Hemostasis during Open Liver Surgery - GATT patch study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GATT Technologies BV
- Enrollment
- 47
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •* 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.
Investigators
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