Colorectal and Ileorectal AnastomosisNCT02841891
A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
A study testing Sylys® Surgical Sealant and Stapled Anastomosis Colectomy Procedure in people with Colorectal and Ileorectal Anastomosis and Colocolic and Ileocolic Anastomosis, run by Cohera Medical, Inc. at 16 sites in United States.
Trial summary
The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colorectal and Ileorectal Anastomosis, Colocolic and Ileocolic Anastomosis, Coloanal and Ileoanal Anastomosis
- What is being tested?
- Sylys® Surgical Sealant and Stapled Anastomosis Colectomy Procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2016to 13 Aug 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 22 years of age or older
- Be scheduled for a colectomy procedure with a stapled anastomosis
- At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%)
- Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
- Agree to return for all follow-up evaluations and procedures specified in the protocol
- Understand and give informed consent
Who cannot join
- Albumin < 3 g/dL
- ASA score (American Society of Anesthesiologists) ≥ 4
- Neutropenia ≤ 800 cells/µl
- Pregnant at time of surgery
- Has AIDS (HIV positive not excluded)
- Has neutropenia (IBD and steroid use not excluded)
Show all 23Show fewer
- Has a known blood clotting disorder requiring treatment
- Has any condition known to effect wound healing, such as collagen vascular disease
- Has known or suspected allergy or sensitivity to any test materials, reagents, or WCE contrast materials
- Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure
- Concurrently using fibrin sealants or other anastomosis care devices
- Emergency surgery for abdominal indications
- Has undergone a colectomy procedure in the previous two months
- Has an emergent infection related to a previous colectomy procedure
- Is scheduled to undergo a Hartmann's procedure
- Is scheduled to undergo trans-anal endoscopic microsurgery (TEM)
- Is scheduled to undergo procedure using omental wrapping
- Is participating in another medical device trial involving colectomy with anastomosis
- First 20 subjects ONLY:
- Is diagnosed with high risk cancer as determined by preoperative clinical evidence or diagnostic imaging (if patient's cancer stage has been downstaged through treatment prior to baseline screening, subject is allowed to be included):
- Lymph Node Cancer Stage: N2
- Cancer Tumor Size: T4
- Circumferential resection margin: CRM+ (Positive)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
Baylor Scott & White Research Institute
Dallas, Texas, 75246
University of Colorado Denver
Denver, Colorado, 80204
Duke University
Durham, North Carolina, 27710
Houston Methodist
Houston, Texas, 77030
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Southern Alabama
Mobile, Alabama, 36617
Tulane
New Orleans, Louisiana, 70112
Ochsner Medical Center
New Orleans, Louisiana, 70121
Intermountain Healthcare
Ogden, Utah, 84403
University of California Irvine
Orange, California, 92868
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Univeristy of Utah
Salt Lake City, Utah, 84132
Stony Brook University Hospital
Stony Brook, New York, 11794
University of South Florida
Tampa, Florida, 33606
About this study
Official title: A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.
- Conditions
- Colorectal and Ileorectal Anastomosis, Colocolic and Ileocolic Anastomosis, Coloanal and Ileoanal Anastomosis
- Being tested
- Sylys® Surgical Sealant, Stapled Anastomosis Colectomy Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sylys® Surgical SealantDevice
Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant
Stapled Anastomosis Colectomy ProcedureProcedure or surgery
Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Test group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure. Receives: Device: Sylys® Surgical Sealant |
| Control | Active comparator | Control group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant. Receives: Procedure: Stapled Anastomosis Colectomy Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications
Number of subjects with anastomosis-related complications
Measured: 26 Weeks
Secondary outcomes (2)
Sealant Application Evaluation Questionnaire
Questionnaire documenting the ability to apply the sealant adequately to the anastomosis
Measured: At time of device application (during surgery)
Reduction in Anastomotic Leaks
Comparison of anastomotic leak rate across all subjects
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Why it stopped: Resource Constraints
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
- 58 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
- NCT02841891
- Sponsor's protocol ID
- PRO-106-0129
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2016
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
- ClinicalTrials.gov ID
- NCT02841891
- Acronym / sponsor ID
- PRO-106-0129
- Conditions
- Colorectal and Ileorectal Anastomosis, Colocolic and Ileocolic Anastomosis, Coloanal and Ileoanal Anastomosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resource Constraints
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 22 Jul 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 prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: Sylys® Surgical SealantTest group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure. |
| Control | Active comparator | Procedure: Stapled Anastomosis Colectomy ProcedureControl group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 22 years of age or older
- Be scheduled for a colectomy procedure with a stapled anastomosis
- At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%)
- Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
- Agree to return for all follow-up evaluations and procedures specified in the protocol
Key exclusion criteria (23 listed)
- Albumin < 3 g/dL
- ASA score (American Society of Anesthesiologists) ≥ 4
- Neutropenia ≤ 800 cells/µl
- Pregnant at time of surgery
- Has AIDS (HIV positive not excluded)
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 SealantStandard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant | Device | Test |
| Stapled Anastomosis Colectomy ProcedureStandard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant | Procedure or surgery | Control |
Primary outcome
Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications
Time frame: 26 Weeks
Number of subjects with anastomosis-related complications
2 secondary outcomes
Sealant Application Evaluation Questionnaire
Time frame: At time of device application (during surgery)
Reduction in Anastomotic Leaks
Time frame: 26 Weeks
Results and safety
The study was stopped early (reason given: Resource Constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sylys® Surgical Sealant and Stapled Anastomosis Colectomy Procedure in people with Colorectal and Ileorectal Anastomosis and Colocolic and Ileocolic Anastomosis, run by Cohera Medical, Inc. at 16 sites in United States.
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 23 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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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: Resource Constraints). 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?
Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications (time frame: 26 Weeks). 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 16 Aug 2018.