CLINICAL

CLINICAL

  • We have finalized recruitment of 30 patients for our ongoing clinical trial.

  • To this point, no treatment-related SAEs (serious adverse events) have been recorded. We estimate that initial efficacy data would be available by April of 2020.

  • The trial is performed with the participation of the Hospital of the Lithuanian University of Health Sciences Kauno Klinikos in Lithuania. 

Details of the clinical trial:

Clinical Evaluation:

  • EIO Biomedical is currently performing clinical study for Evaluation of the feasibility, safety, initial efficacy and usability of FuseX Anti-Adhesion system toward further studies that will be powered to prove its safety and efficacy. In addition, this initial study will serve to yield blood bank and surgeon feedback towards improving the system.

Study title:

  • Prospective, randomized, double blinded, parallel, controlled, two-arm, single-center evaluation of the feasibility, safety, initial efficacy and clinical usability of FuseX Anti-Adhesion system.

Estimated Study start date:

  • April 2018

Estimated Primary Completion Date:

  • April 2020

Study location:

  • Lithuanian university of health sciences Kauno klinikos, Kaunas, Lithuania

Enrollment:

  • 30

Inclusion:

  • PREOPERATIVE INCLUSION - Preoperatively the patient must:

    • Understand and be able to follow the requirements of the protocol including signing and dating an Ethics Committee approved Informed Consent prior to undergoing any protocol related procedures (or informed consent obtained from the the subject's legally authorized representative prior to study entry)

  • Patients undergoing any of the above procedures

    • Male or female subjects > 18 years of age

    • Subjects for whom a second abdominal surgery is planned within less than 12 months of the first surgical procedure 5. BMI<40

  • INTRAOPERATIVE INCLUSION - During surgery the patient must require having one of the following surgeries performed on their person:

    • Planned or emergency colonic resection surgery with temporary stoma creation due to colonic perforation, acute diverticulitis or colonic obstruction.

    •  Surgery for low rectal cancer - low anterior resection. This surgery includes resection of lower part of rectum, colo-anal anastomosis and protective ileostomy creation. Usually patient undergo second stage procedure closure of ileostomy in 1-3 months.

    • Total proctocolectomy and a pelvic pouch with diverting ileostomy in cases of surgery for Ulcerative colitis. In this kind of surgery there is the intention to close the temporary ileostomy in 1-3 months.

    • Creation of stoma due to infectious process or trauma in the peritoneum (such as Fournier gangrene, laceration of rectum, etc')

Exclusion:

  • PREOPERATIVE EXCLUSION - Preoperatively a patient must not:

    • Be unable to give their own written informed consent,

    • Be currently enrolled in another clinical study with drug or device related to adhesions or has participated in such a study within the last 30 days,

    • Have received or is expected to receive any other investigational product or technique belonging to the group of hemostats, adhesion reduction devices or other products, meshes, or other types of implants in the abdominal cavity within 30 days prior to or during enrolment,

    • Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation

    • BMI>40

    • Subjects who have received selective factor Xa inhibitors and/or direct thrombin inhibitors within 24 hours prior to surgery.

    • Patients taking immune system suppressants deemed by the surgeon to interfere with wound healing, Patients taking daily doses of corticosteroids exceeding 20mg within the prior 30 days are to be excluded. Patients requiring perioperative corticosteroid supplementation are not to be excluded.

    • Patients with a known history of severe multiple drug allergies

    • Patients who have a life expectancy of less than 6 months because of a medical condition or disease state

    • Any patient with a medical condition or other serious condition which will interfere with compliance and/or ability to complete this study protocol or who in the opinion of the investigator would not be a good candidate for enrolment

  • INTRAOPERATIVE EXCLUSION

    • Patients for whom it is known, prior to the initial procedure, that loop ileostomy or colostomy closure is not feasible for any reason

    • Patients with peritoneal carcinomatosis

    • patients with endometriosis

    • Use of hernia mesh in the first surgery.

    • Subjects treated with hemostatic agents in which the sealant remains in the patient’s body (e.g. Fibrin sealant).

Contact for more information:

Information updated: 

  • September 16th 2019

AVERAGE ADHESION AREA

Site by: Hila rahat                                                                                                                                                                             2017 EIOBIO | All Rights Reserved