Actively Recruiting
Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2024-07-30
120
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center trial that enrolls 120 18- to 85-year-old patients with mild to moderate chronic functional constipation to study the dose-response relationship of the Vibrabot capsule as well as the mechanism of action of the Vibrabot capsule.
CONDITIONS
Official Title
Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 85 years old men and women
- Have moderate to severe functional constipation based on Rome IV criteria
- Meet two or more symptoms such as straining, hard stools, incomplete evacuation, obstruction sensation, manual maneuvers for defecation, or fewer than 3 bowel movements per week
- Loose stools are rare without laxative use
- Symptoms present for at least 3 months with onset at least 6 months prior
- Colonoscopy within 3 years with negative or mild results or investigator approval if no report
- Polypectomy patients eligible after 1 month for small polyps or 3 months for larger polyps
- Able to communicate, understand study procedures, and sign informed consent
You will not qualify if you...
- Not eligible or refusing abdominal surgery
- Known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, or fistula
- Allergy to polymeric materials
- Implanted cardiac or gastrointestinal pacemakers
- Abdominal aortic aneurysms, vascular lesions, ulcers, or bleeding tendency
- Difficulty swallowing
- Severe depression, anxiety, or acute gastrointestinal lesions
- Prior gastrointestinal surgery altering the structure (except appendectomy) or recent ESD
- Severe hemorrhoids (grade III-IV)
- Planning to have MRI soon
- Pregnant or planning pregnancy within a year
- Other conditions deemed ineligible by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
XuanJiang
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
Research Team
X
Xuan Jiang, Professor
CONTACT
T
Ting Yi, Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here