Clinical trial NCT03820713: Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
Official title: Prospective, Randomized, Double Blinded, Parallel, Controlled, Two-arm, Two-center Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Postoperative Adhesions
Lead sponsor: Eio Biomedical Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double blinded, parallel, controlled, two-arm, two-center
Primary purpose: PREVENTION

Brief summary: Evaluation of the feasibility, safety, initial efficacy and usability of FuseX Anti-Adhesion system toward further studies that will be powered to proved its safety and efficacy. In addition, this initial study will serve to yield blood bank and surgeon feedback towards improving the system.


Eligibility criteria: Inclusion criteria

PREOPERATIVE INCLUSION

Preoperatively the patient must:

1. 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
2. Patients undergoing any of the above procedures
3. Male or female subjects \> 18 years of age
4. 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:

1. Planned or emergency colonic resection surgery with temporary stoma creation due to colonic perforation, acute diverticulitis or colonic obstruction.
2. 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.
3. 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.
4. Creation of stoma due to infectious process or trauma in the peritoneum (such as Fournier gangrene, laceration of rectum, etc.)

Exclusion Criteria

PREOPERATIVE EXCLUSION

Preoperatively a patient must not:

1. be unable to give their own written informed consent,
2. 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,
3. 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,
4. subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation for reasons other than rectal carcinoma.
5. BMI≥40
6. Subjects who have received selective factor Xa inhibitors and/or direct thrombin inhibitors within 24 hours prior to surgery.
7. 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.
8. Patients with a known history of severe multiple drug allergies
9. Patients who have a life expectancy of less than 6 months because of a medical condition or disease state
10. 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 enrollment

INTRAOPERATIVE EXCLUSION

1. Patients for whom it is known, prior to the initial procedure, that loop ileostomy or colostomy closure is not feasible for any reason
2. Patients with peritoneal carcinomatosis
3. Patients with endometriosis
4. Use of hernia mesh in the first surgery.
5. Subjects treated with hemostatic agents in which the sealant remains in the patient's body (e.g. Fibrin sealant).

Primary outcomes:
measure: Treatment-emergent adverse event incidence
timeFrame: Within 30 days from the first surgery
measure: Overall adverse event incidence
timeFrame: Until the second surgery but not longer than 7 months
measure: Severity of new formed adhesions in the target region
timeFrame: Through study completion, an average of 1 year
measure: Usability as assessed by Surgeon questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Usability as assessed by Operator questionnaire
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Incidence of general surgical complications; incidence of minor adverse events
timeFrame: Until the second surgery but not longer than 7 months
measure: Usability of the device Instructions for Use (questionnaire)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Kaunas Clinical Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Study officials:
affiliation: EIO Biomedical Ltd., Medical Adviser
name: Rafael Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: