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Procedure
Colonoscope Type for Obesity
Weston, FL
N/A
Recruiting
Research Sponsored by Cleveland Clinic Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI greater than 30
Must not have
Terminated procedure due to stool burden, stenosis, or obstructive mass
Inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of randomization to end of procedure. assessed day of surgery.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine which type of colonoscope is more effective for people with a high body mass index. Currently, doctors choose between pediatric and adult colonoscopes based on personal preference and availability.
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Who is the study for?
This trial is for individuals with a BMI over 30 who need a routine colonoscopy, either as a regular check-up or to keep an eye on existing conditions. It's not suitable for those with inflammatory bowel disease, previous colon surgery, or if they've had trouble completing a colonoscopy before due to technical issues.Check my eligibility
What is being tested?
The study aims to determine whether pediatric or adult colonoscopes are more effective in obese patients undergoing screening and surveillance colonoscopies. Participants will be randomly assigned one of the two types of scopes after their bowels have been cleansed.See study design
What are the potential side effects?
Colonoscopy may cause discomfort, bloating, cramping, and risk of perforation or bleeding. The side effects might vary slightly depending on whether the pediatric or adult scope is used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is over 30.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My procedure was stopped because of blockage or a large stool mass.
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I have inflammatory bowel disease.
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I had a colonoscopy because of anemia.
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I have had surgery on my colon.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of randomization to end of procedure. assessed day of surgery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of randomization to end of procedure. assessed day of surgery.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite of reaching the cecum in less than 10 minutes without changing the scope type.
Secondary study objectives
Ancillary maneuvers used
Cecal intubation rate (CIR)
Insertion time (IT)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Adult ColonoscopeActive Control1 Intervention
Adult colonoscope
Group II: Pediatric ColonoscopeActive Control1 Intervention
Pediatric colonoscope
Find a Location
Closest Location:Cleveland Clinic Weston· Weston, FL· 971 miles
Who is running the clinical trial?
Cleveland Clinic FloridaLead Sponsor
15 Previous Clinical Trials
6,572 Total Patients Enrolled