Colorectal and Ileorectal AnastomosisNCT02960139
A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant
A study testing Test- Treatment with Sylys Surgical Sealan in people with Colorectal and Ileorectal Anastomosis, run by Cohera Medical, Inc. at 6 sites in Netherlands.
Trial summary
The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colorectal and Ileorectal Anastomosis
- What is being tested?
- Test- Treatment with Sylys Surgical Sealan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 6 sitesNetherlands
- Study dates
- 13 Apr 2017to 31 May 2018
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 22 years of age
- Be scheduled for a stapled colorectal or ileorectal anastomosis procedure with or without diverting stoma
- Agree to return for all follow-up evaluations and procedures specified in the protocol
- Understand and give informed consent
Who cannot join
- Albumin < 3
- ASA ≥ 4
- Neutropenia ≤ 800
- Pregnancy
- The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
- Known blood clotting disorder requiring treatment
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- Any condition known to effect wound healing, such as collagen vascular disease
- Have known or suspected allergy or sensitivity to any test materials or reagents
- Concurrent use of fibrin sealants or other anastomosis care devices
- Surgery for emergency abdominal indications
- Has undergone a colorectal anastomosis procedure in the previous two months
- Has an emergent infection related to a previous colorectal anastomosis procedure
- Is scheduled to undergo a Hartmann's procedure
- Is scheduled to undergo trans-anal endoscopic microsurgery (TEM) Is participating in another medical device trial related to colorectal anastomosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Flevoziekenhuis
Almere Stad, Flevoland
Meander Medical Center
Amersfoort
OLVG
Amsterdam
AMC
Amsterdam-Zuidoost
Laurentius
Roermond
Diakonessenhuis
Utrecht
About this study
Official title: A Pivotal, Prospective, Randomized, Controlled, Multicenter Superiority Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant
The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures.
- Conditions
- Colorectal and Ileorectal Anastomosis
- Being tested
- Test- Treatment with Sylys Surgical Sealan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test- Treatment with Sylys Surgical SealanDevice
Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant
| Study group | Role | What they receive |
|---|---|---|
| Test- Treatment with Sylys Surgical Sealant | Experimental | Standard closure plus treatment with Sylys Surgical Sealant Receives: Device: Test- Treatment with Sylys Surgical Sealan |
| Control- Standard of Care | No intervention | Control group is standard closure of anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of the incidence of anastomosis-related complications
Measured: from day of surgery to week 26
Secondary outcomes (1)
A comparison of the proportion of patients who have incidence of sub-clinical or clinical anastomotic leaks
A comparison of the proportion of patients who have either sub-clinical or clinical anastomotic leaks in each group.
Measured: 14 days, 12 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start13 Apr 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Why it stopped: Protocol updates resulted in new protocol/study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal and Ileorectal AnastomosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cohera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960139
- Sponsor's protocol ID
- PRO-106-0119
- Status last verified
- Jun 2018
- First submitted
- 3 Nov 2016
- Last updated
- 14 Jun 2018
- 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 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Prospective, Randomized, Controlled, Multicenter Superiority Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant
- ClinicalTrials.gov ID
- NCT02960139
- Acronym / sponsor ID
- PRO-106-0119
- Conditions
- Colorectal and Ileorectal Anastomosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol updates resulted in new protocol/study
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 9 Nov 2016 (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.
The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test- Treatment with Sylys Surgical Sealant | Experimental | Device: Test- Treatment with Sylys Surgical SealanStandard closure plus treatment with Sylys Surgical Sealant |
| Control- Standard of Care | No intervention | –Control group is standard closure of anastomosis. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 22 years of age
- Be scheduled for a stapled colorectal or ileorectal anastomosis procedure with or without diverting stoma
- Agree to return for all follow-up evaluations and procedures specified in the protocol
- Understand and give informed consent
Key exclusion criteria (14 listed)
- Albumin < 3
- ASA ≥ 4
- Neutropenia ≤ 800
- Pregnancy
- The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
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 |
|---|---|---|
| Test- Treatment with Sylys Surgical SealanStandard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant | Device | Test- Treatment with Sylys Surgical Sealant |
Primary outcome
A comparison of the incidence of anastomosis-related complications
Time frame: from day of surgery to week 26
1 secondary outcome
A comparison of the proportion of patients who have incidence of sub-clinical or clinical anastomotic leaks
Time frame: 14 days, 12 weeks, 26 weeks
Results and safety
The study was stopped early (reason given: Protocol updates resulted in new protocol/study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
Related trials for Colorectal and Ileorectal Anastomosis
Active, not recruitingObservational study
Familial Adenomatous Poliposys Italian Network (Rete Italiana Poliposi Adenomatosa Familiare)
Familial Adenomatous Polyposis (FAP), Attenuated Familial Adenomatous Polyposis (AFAP)
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test- Treatment with Sylys Surgical Sealan in people with Colorectal and Ileorectal Anastomosis, run by Cohera Medical, Inc. at 6 sites in Netherlands.
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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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.
Are results available for this study?
The study was stopped early (reason given: Protocol updates resulted in new protocol/study). Results are not available in the source record.
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?
A comparison of the incidence of anastomosis-related complications (time frame: from day of surgery to week 26). 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 14 Jun 2018.