Actively Recruiting
Efficacy and Safety of the CG-100 Intraluminal Bypass Device
Led by Colospan Ltd. · Updated on 2025-10-23
250
Participants Needed
14
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
CONDITIONS
Official Title
Efficacy and Safety of the CG-100 Intraluminal Bypass Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to comply with follow-up evaluations as per the study protocol
- Aged 22 to 65 years, or 66 to 70 years with up to one treated cardiovascular, metabolic, or pulmonary condition
- Diagnosed with colorectal cancer
- Scheduled for elective open, laparoscopic, or robotic mesorectal excision with an anastomosis up to 10 cm from the anal verge
- Scheduled to receive a protective stoma during the primary planned surgery
- Planned mechanical bowel preparation before surgery
- Provided informed consent approved by an ethics committee or institutional review board
You will not qualify if you...
- Presence of local or systemic infection at the time of intervention, such as peritonitis
- Major surgical or interventional procedures within 45 days before the study or planned within 6 months after entry (except port placement for chemotherapy or ureter stent insertion)
- ASA classification greater than 3
- Albumin level below 30 g/liter
- Diagnosis of bowel obstruction, strangulation, peritonitis, perforation, ischemic bowel, carcinomatosis, or widespread inflammatory bowel disease
- Diagnosis of coagulopathy, thrombocytopenia, or immune suppression
- Body mass index of 40 or higher
- Undergoing additional surgical procedures during surgery other than ileostomy or adhesiolysis
- Current participation in another investigational drug or device study unless approved by the sponsor
- Regular systemic or steroid medication use in the last 6 months
- Use of antimetabolites or antiplatelet agents
- Preexisting sphincter problems
- Extensive local disease in the pelvis or prior pelvic anastomosis
- Massive diverticulosis in the sigmoid or descending colon seen on preoperative CT
- Any condition that could jeopardize safe participation or data quality as judged by the investigator
- Pregnant or nursing females; females of childbearing potential must have a negative pregnancy test within 7 days before surgery
AI-Screening
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Trial Site Locations
Total: 14 locations
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Kaiser Permanente San Diego medical Center
San Diego, California, United States, 92123
Actively Recruiting
3
Colorado University Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Louisville
Louisville, Kentucky, United States, 40202
Active, Not Recruiting
5
Henry Ford Health System
Detroit, Michigan, United States, 48202
Active, Not Recruiting
6
East Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Active, Not Recruiting
7
New York-Presbyterian / Weill Cornell Medical Center
New York, New York, United States, 10021
Active, Not Recruiting
8
Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
9
Lifespan & Brown Surgical Associates
Providence, Rhode Island, United States, 02906
Active, Not Recruiting
10
University of Utah Health
Salt Lake City, Utah, United States, 84132
Active, Not Recruiting
11
Soroka University Medical Center
Beersheba, Israel, 85025
Actively Recruiting
12
Carmel Medical Center
Haifa, Israel, 8250490
Actively Recruiting
13
Rabin Medical Center
Petah Tikva, Israel, 49100
Withdrawn
14
Humanitas Research Hospital
Milan, Lombardy, Italy, 20089
Actively Recruiting
Research Team
J
Jonathan Elsner, PhD, MBA
CONTACT
S
Shelly Sharon, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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