Stoma Reversal ProcedureNCT02196519
Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure
A study testing Sylys Surgical Sealant in people with Stoma Reversal Procedure, run by Cohera Medical, Inc..
Trial summary
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Reversal Procedure
- What is being tested?
- Sylys Surgical Sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Sep 2013
- 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
- Be at least 18 years of age
- Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications
- Be scheduled for an ileostomy reversal procedure
- Be willing to follow instructions for incision care
- Agree to return for all follow-up evaluations specified in this protocol
- Sign informed consent
Who cannot join
- Anesthesia risk judged to be higher than ASA2
- Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
- Any condition involving compromised immune system
- Any condition known to effect wound healing, such as collagen vascular disease
- Known blood clotting disorder
- Be receiving antibiotic therapy for pre-existing condition or infection
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- Concurrent use of fibrin sealants or other anastomosis care devices
- Be currently taking systemic steroids or immunosuppressive agents
- Have known or suspected allergy or sensitivity to any test materials or reagents
- Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
About this study
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.
- Conditions
- Stoma Reversal Procedure
- Being tested
- Sylys Surgical Sealant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sylys Surgical SealantDevice
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure. Receives: Device: Sylys Surgical Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma Reversal ProcedureStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cohera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- W Bemelman, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)E Consten, Principal investigator, Meander Medical Center- Amersfoort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196519
- Sponsor's protocol ID
- PRO-106-0028
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure
- ClinicalTrials.gov ID
- NCT02196519
- Acronym / sponsor ID
- PRO-106-0028
- Conditions
- Stoma Reversal Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Jul 2014 (estimated)
- 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.
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: Sylys Surgical SealantAll test arm subjects received Sylys Surgical sealant around anastomotic junction after closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years of age
- Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications
- Be scheduled for an ileostomy reversal procedure
- Be willing to follow instructions for incision care
- Agree to return for all follow-up evaluations specified in this protocol
Key exclusion criteria (10 listed)
- Anesthesia risk judged to be higher than ASA2
- Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
- Any condition involving compromised immune system
- Any condition known to effect wound healing, such as collagen vascular disease
- Known blood clotting disorder
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 |
|---|---|---|
| Sylys Surgical Sealant | Device | Test |
Primary outcome
Number of Adverse Events
Time frame: 30 days
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 22 Jul 2014.
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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.
W Bemelman principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
E Consten principal investigator
Meander Medical Center- Amersfoort
Questions about this trial
What is this clinical trial studying?
A study testing Sylys Surgical Sealant in people with Stoma Reversal Procedure, run by Cohera Medical, Inc..
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 6 inclusion and 10 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 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Number of Adverse Events (time frame: 30 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 22 Jul 2014.