Actively Recruiting
Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance
Led by Evergreen General Hospital, Taiwan · Updated on 2024-11-05
400
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
Sponsors
E
Evergreen General Hospital, Taiwan
Lead Sponsor
E
E-Da Dachange Hospital, Kaohsiung, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this trial is to evaluate whether water exchange colonoscopy and CO2-insufflation colonoscopy with an abdominal compression device (Maxbelt me3 type, Nippon Sigmax Co., Tokyo, Japan) can achieve a significantly lower proportion of patients requiring manual abdominal pressure during colonoscopic insertion compared with CO2 insufflation alone.
CONDITIONS
Official Title
Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 45-80 years having an average risk for colorectal cancer who plan to undergo sedated outpatient colonoscopy for screening, surveillance, and those who have received a positive fecal immunochemical test result
You will not qualify if you...
- Patients with hereditary colorectal cancer syndrome, including familial adenomatous polyposis and hereditary nonpolyposis colorectal cancer (Lynch syndrome)
- Patients with serrated polyposis syndrome
- Patients with known or suspected inflammatory bowel disease
- Patients with a history of colorectal cancer or other intra-abdominal malignancy
- Patients with a history of colorectal resection
- Patients with a history of abdominal aortic aneurysm, cirrhosis, ascites, or other severe comorbid illnesses
- Patients with recent wounds or skin rash on the anterior abdominal wall and back
- Patients with known ventral hernia
- Patients with unsedated procedure
- Patients with planned bidirectional endoscopy
- Patients with body mass index >35 kg/m2
- Patients with waist circumference <55 cm or >105 cm
- Patients with known or suspected gastroparesis
- Patients with planned therapeutic procedures (e.g., hemostasis, removal of a large polyp)
- Patients with mental retardation
- Pregnant women or those planning pregnancy
- Patients unwilling to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
E-Da Dachang Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
2
Evergreen General Hospital
Taoyuan, Taiwan, 320
Actively Recruiting
Research Team
C
Chi-Liang Cheng, MD
CONTACT
J
Jen-Hao Yeh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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