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CSPR vs Cold EMR for Colon Polyps (CARDINAL Trial)
N/A
Waitlist Available
Led By John J Guardiola, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years of age
Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
Must not have
Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare using two different methods, cold snare piecemeal resection (CSPR) and cold endoscopic mucosal resection (Cold EMR), for removing abnormal growth
Who is the study for?
Adults undergoing colonoscopy who have a sessile serrated lesion or hyperplastic polyp ≥ 10 mm, or a conventional adenoma sized 10-19 mm. Not for those with polyps in locations hard to reach endoscopically, stalked polyps, signs of deeper invasion, or with Ulcerative Colitis/Crohn's disease.
What is being tested?
The trial compares two methods of removing certain types of colon polyps: Cold Snare Piecemeal Resection (CSPR) and Cold Endoscopic Mucosal Resection (Cold EMR), focusing on different sizes and types of lesions.
What are the potential side effects?
Potential side effects may include bleeding, pain at the resection site, perforation of the colon wall, infection risk post-procedure. These risks are generally low but vary based on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am going for a colonoscopy.
Select...
I have a large polyp or adenoma found during a procedure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have polyps that can't be removed with a scope due to their location.
Select...
My polyps are attached to my colon by a stalk.
Select...
My polyps are not identified as sessile serrated lesions or hyperplastic.
Select...
I have Ulcerative Colitis or Crohn's disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of Resection (Central Post-Resection Biopsies)
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cold Snare Piecemeal Resection (CSPR)Experimental Treatment1 Intervention
Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique.
Group II: Cold Snare Endoscopic Mucosal Resection (Cold EMR)Experimental Treatment1 Intervention
Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,040 Previous Clinical Trials
1,219,779 Total Patients Enrolled
Rush University Medical CenterOTHER
436 Previous Clinical Trials
248,967 Total Patients Enrolled
Carilion ClinicOTHER
82 Previous Clinical Trials
15,088 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
76 Previous Clinical Trials
354,500 Total Patients Enrolled
John D. Dingell VA Medical CenterFED
9 Previous Clinical Trials
776 Total Patients Enrolled
White River Junction Veterans Affairs Medical CenterFED
31 Previous Clinical Trials
17,634 Total Patients Enrolled
The University of Kansas Medical CenterUNKNOWN
2 Previous Clinical Trials
585 Total Patients Enrolled
Vancouver Coastal HealthOTHER_GOV
39 Previous Clinical Trials
716,885 Total Patients Enrolled
Université de MontréalOTHER
221 Previous Clinical Trials
104,007 Total Patients Enrolled
John J Guardiola, MDPrincipal InvestigatorIndiana University