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| ID | Type | Description | Link |
|---|---|---|---|
| CL-PL-057-01 | Other Identifier | EIO Biomedical Ltd. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational arm | Experimental | Treatment group receives a concentrate of coagulation factors. The device concentrates coagulation factors from donor plasma; the concentrate is applied to the surgical site intended to reduce the incidence, extent and severity of postoperative adhesions. |
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| Control arm | Placebo Comparator | Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concentrate of plasma coagulation factors | Procedure | The plasma concentrate of coagulation factors is applied to the surgical site. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse event incidence | Incidence of adverse events related to treatment requiring any invasive procedure in the test group (who used blood plasma concentrate prepared using FuseX Anti-Adhesion System) compared to control group (who used normal saline processed by the same FuseX Anti-Adhesion System). | Within 30 days from the first surgery |
| Overall adverse event incidence | Overall adverse event incidence will be evaluated by the presence and severity of adverse events and serious adverse events in the test group (who used blood plasma concentrate prepared using FuseX Anti-Adhesion System) vs. control group (who used normal saline processed by the same FuseX Anti-Adhesion System). | Until the second surgery but not longer than 7 months |
| Severity of new formed adhesions in the target region | Severity of new formed adhesions having its source in the target region will be assessed by a blinded surgeon during the second surgery by grading the adhesion severity for each region on a scale from 0 (no adhesions) to 3 (strong vascularized adhesions that require sharp dissection and cannot be separated without tissue damage). The peritoneal cavity will be divided into 9 separate scoring regions. A peritoneal adhesion index (PAI) (sum of scores for all the regions) will be calculated per each patient. | Through study completion, an average of 1 year |
| Usability as assessed by Surgeon questionnaire | a. Ease of application will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy). b. Percentage of coverage the entire defined surgical field. c. mL of the materials used | Through study completion, an average of 1 year |
| Usability as assessed by Operator questionnaire | a. Ease of device use will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy). b. Device operation time |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of general surgical complications; incidence of minor adverse events | Incidence of general surgical complications including but not limited to:
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Inclusion criteria
PREOPERATIVE INCLUSION
Preoperatively the patient must:
INTRAOPERATIVE INCLUSION
During surgery the patient must require having one of the following surgeries performed on their person:
Exclusion Criteria
PREOPERATIVE EXCLUSION
Preoperatively a patient must not:
INTRAOPERATIVE EXCLUSION
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Miller, MD | EIO Biomedical Ltd., Medical Adviser | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaunas Clinical Hospital | Kaunas | LT-47144 | Lithuania | |||
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Prospective, randomized, double blinded, parallel, controlled, two-arm, two-center
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| 0.9% saline | Procedure | Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma. |
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| Through study completion, an average of 1 year |
| Until the second surgery but not longer than 7 months |
| Usability of the device Instructions for Use (questionnaire) | Usability of the device user manual will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy). | Through study completion, an average of 1 year |
| Kaunas |
| LT-50009 |
| Lithuania |