A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
NCT ID: NCT02841891
Last Updated: 2018-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
58 participants
INTERVENTIONAL
2016-07-31
2018-08-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant
NCT02960139
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
NCT00663819
Single-stapled Double Purse-string Technique for Colorectal Anastomosis
NCT04223141
ReAL Trial (Rectal Anastomotic seaL)
NCT03941938
Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.
NCT03423485
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test
Test group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure.
Sylys® Surgical Sealant
Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant
Control
Control group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant.
Stapled Anastomosis Colectomy Procedure
Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sylys® Surgical Sealant
Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant
Stapled Anastomosis Colectomy Procedure
Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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)
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cohera Medical, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern Alabama
Mobile, Alabama, United States
University of California Irvine
Orange, California, United States
University of Colorado Denver
Denver, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Tulane
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Duke University
Durham, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Houston Methodist
Houston, Texas, United States
Intermountain Healthcare
Ogden, Utah, United States
Univeristy of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO-106-0129
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.