Gastrointestinal DiseasesPhase 2NCT01589822
The EVICEL® Gastrointestinal Study
A Phase 2 study testing EVICEL Fibrin Sealant in people with Gastrointestinal Diseases, run by Ethicon, Inc. at 22 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- EVICEL Fibrin Sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 22 sitesin 7 countries
- Study dates
- Jun 2012to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects undergoing primary elective GI surgery
- Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures
Who cannot join
- Avastin use within 30 days prior to surgery;
- Known hypersensitivity to the human blood products or the components of the investigational product;
- Female subjects who are pregnant or nursing;
- Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States8 sites
Clinical Investigation Site #5
Augusta, Georgia, 30912
Clinical Investigation Site #23
Greenville, South Carolina, 29605
Clinical Investigation Site #3
Houston, Texas, 77030
Clinical Investigation Site #6
Houston, Texas, 77030
Clinical Investigation Site #1
Irvine, California, 92868
Clinical Investigation Site #2
Jacksonville, Florida, 32099
Clinical Investigation Site #4
New Orleans, Louisiana, 70121
Clinical Investigation Site #8
Portland, Oregon, 97239
United Kingdom5 sites
Clinical Investigation Site #15
Edinburgh, EH42XU
Clinical Investigation Site #11
Leicester, LE15WW
Clinical Investigation Site #12
Nottingham, NG72UH
Clinical Investigation Site #13
Plymouth, PL68DH
Clinical Investigation Site #14
Sheffield, S57AU
Australia2 sites
Clinical Investigation Site #19
New Lambton, New South Wales, 2305
Clinical Investigation Site #18
South Adelaide, 6010
Belgium2 sites
Clinical Investigation Site #17
Genk, 3600
Clinical Investigation Site #16
Ghent, 9000
Canada2 sites
Clinical Investigation Site #9
Toronto, Ontario, M5G 1X5
Clinical Investigation Site #10
Vancouver, British Columbia, V6Z 1Y6
South Korea2 sites
Clinical Investigation Site #22
Seoul, 138-736
Clinical Investigation Site #21
Seoul
About this study
Official title: A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
Read the detailed description
This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL® when used as an adjunct to gastrointestinal (GI) surgery.
- Conditions
- Gastrointestinal Diseases
- Being tested
- EVICEL Fibrin Sealant
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVICEL Fibrin SealantBiological
Also called Fibrin sealant
Intraoperative
| Study group | Role | What they receive |
|---|---|---|
| EVICEL Fibrin Sealant: Randomized | Experimental | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. Receives: Biological: EVICEL Fibrin Sealant |
| Standard of Care | No intervention | Standard surgical technique for GI anastomosis. |
| Experimental: EVICEL Fibrin Sealant: Non-Randomized | Experimental | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen Receives: Biological: EVICEL Fibrin Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Gastrointestinal (GI) Leak
Measured: 40 days
Secondary outcomes (3)
Incidence of Adverse Events
Measured: up to Day 90
Incidence of GI Leak
Measured: 90 days
Incidence of Stricture
Measured: up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kocharian, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589822
- Sponsor's protocol ID
- 400-11-002
- Status last verified
- Feb 2015
- First submitted
- 30 Apr 2012
- Last updated
- 25 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
- ClinicalTrials.gov ID
- NCT01589822
- Acronym / sponsor ID
- 400-11-002
- Conditions
- Gastrointestinal Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Posted 25 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
Detailed description
This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL® when used as an adjunct to gastrointestinal (GI) surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVICEL Fibrin Sealant: Randomized | Experimental | Biological: EVICEL Fibrin SealantEVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. |
| Standard of Care | No intervention | –Standard surgical technique for GI anastomosis. |
| Experimental: EVICEL Fibrin Sealant: Non-Randomized | Experimental | Biological: EVICEL Fibrin SealantEVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects undergoing primary elective GI surgery
- Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures
Key exclusion criteria (4 listed)
- Avastin use within 30 days prior to surgery;
- Known hypersensitivity to the human blood products or the components of the investigational product;
- Female subjects who are pregnant or nursing;
- Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.
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 |
|---|---|---|
| EVICEL Fibrin SealantAlso: Fibrin sealantIntraoperative | Biological | EVICEL Fibrin Sealant: Randomized, Experimental: EVICEL Fibrin Sealant: Non-Randomized |
Primary outcome
Absence of Gastrointestinal (GI) Leak
Time frame: 40 days
3 secondary outcomes
Incidence of Adverse Events
Time frame: up to Day 90
Incidence of GI Leak
Time frame: 90 days
Incidence of Stricture
Time frame: up to Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Kocharian, MD study director
Ethicon, Inc.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVICEL Fibrin Sealant in people with Gastrointestinal Diseases, run by Ethicon, Inc. at 22 sites in 7 countries.
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 2 inclusion and 4 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 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, United Kingdom, Australia, Belgium, Canada and 2 more countries. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absence of Gastrointestinal (GI) Leak (time frame: 40 days). 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 25 Feb 2015.