Reduction of Postoperative AdhesionsNCT03820713
Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
A study testing Concentrate of plasma coagulation factors and 0.9% saline in people with Reduction of Postoperative Adhesions, run by Eio Biomedical Ltd. at 2 sites in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction of Postoperative Adhesions
- What is being tested?
- Concentrate of plasma coagulation factors and 0.9% saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesLithuania
- Study dates
- 9 May 2018to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
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- 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.)
Who cannot join
- 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 for reasons other than rectal carcinoma.
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- 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 enrollment
- 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).
Trial locations and contacts
2 sites in 1 country.
Lithuania2 sites
Kaunas Clinical Hospital
Kaunas, LT-47144
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, LT-50009
About this study
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
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.
- Conditions
- Reduction of Postoperative Adhesions
- Being tested
- Concentrate of plasma coagulation factors, 0.9% saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrate of plasma coagulation factorsProcedure or surgery
The plasma concentrate of coagulation factors is applied to the surgical site.
0.9% salineProcedure or surgery
Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Concentrate of plasma coagulation factors |
| Control arm | Placebo comparator | Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma. Receives: Procedure: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Through study completion, an average of 1 year
Usability as assessed by Surgeon questionnaire
- 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
Measured: Through study completion, an average of 1 year
Usability as assessed by Operator questionnaire
- Ease of device use will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy). b. Device operation time
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Incidence of general surgical complications; incidence of minor adverse events
Incidence of general surgical complications including but not limited to:
- Septic shock, cardiovascular events, respiratory tract infections and pulmonary atelectasis, urinary tract infections, thromboembolic events
- Superficial Surgical Site Infections (SSI) - soft tissue infection, cellulitis, incisional abscess, wound dehiscence
- Deep SSI - abdominal abscess, pelvic abscess, peritonitis. Incidence of minor adverse events such as nausea, vomiting, abdominal pain, ileus, allergic reactions
Measured: 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).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start9 May 2018
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Postoperative AdhesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double blinded, parallel, controlled, two-arm, two-center
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eio Biomedical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rafael Miller, MD, Principal investigator, EIO Biomedical Ltd., Medical Adviser
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820713
- Sponsor's protocol ID
- AOS-CL1000-02
- Other IDs
- CL-PL-057-01
- Status last verified
- Jul 2020
- First submitted
- 12 Aug 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03820713
- Acronym / sponsor ID
- AOS-CL1000-02
- Conditions
- Reduction of Postoperative Adhesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eio Biomedical Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 May 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blinded, parallel, controlled, two-arm, two-center
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | Experimental | Procedure: Concentrate of plasma coagulation factorsTreatment 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. |
| Control arm | Placebo comparator | Procedure: 0.9% salineControl group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- PREOPERATIVE INCLUSION
- 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
- 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
Key exclusion criteria (18 listed)
- PREOPERATIVE EXCLUSION
- 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 for reasons other than rectal carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentrate of plasma coagulation factorsThe plasma concentrate of coagulation factors is applied to the surgical site. | Procedure or surgery | Investigational arm |
| 0.9% salineControl group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma. | Procedure or surgery | Control arm |
Primary outcome
Treatment-emergent adverse event incidence
Time frame: Within 30 days from the first surgery
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).
Overall adverse event incidence
Time frame: Until the second surgery but not longer than 7 months
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).
Severity of new formed adhesions in the target region
Time frame: Through study completion, an average of 1 year
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.
Usability as assessed by Surgeon questionnaire
Time frame: Through study completion, an average of 1 year
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
Usability as assessed by Operator questionnaire
Time frame: Through study completion, an average of 1 year
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
2 secondary outcomes
Incidence of general surgical complications; incidence of minor adverse events
Time frame: Until the second surgery but not longer than 7 months
Usability of the device Instructions for Use (questionnaire)
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Miller, MD principal investigator
EIO Biomedical Ltd., Medical Adviser
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrate of plasma coagulation factors and 0.9% saline in people with Reduction of Postoperative Adhesions, run by Eio Biomedical Ltd. at 2 sites in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse event incidence (time frame: Within 30 days from the first surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.