Actively Recruiting
The Cap-Assisted Resection Margin Assessment (CARMA) Technique After Polyp Resection: a Prospective Feasibility Study of a Novel Approach to Reduce Polyp Recurrence
Led by Princess Alexandra Hospital, Brisbane, Australia · Updated on 2021-11-15
60
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new technique called the Cap Assisted Resection Margin Assessment (CARMA) to help reduce the recurrence of colonic polyps after they are removed by colonoscopy. Polyps can lead to colorectal cancer if not completely removed, and current methods sometimes miss incomplete resections. The CARMA technique aims to provide a standard way to carefully check the edges of the removed area using advanced endoscopy tools like narrow band imaging and magnification. Participants in this study will first have their polyps removed using standard polypectomy methods. Then, the CARMA technique will be applied to examine the entire margin of the polypectomy site using a cap-assisted magnification endoscope. This assessment may include narrow band imaging at the doctor's discretion. This approach is being studied during the initial procedure to detect any leftover polyp tissue and ensure a clear margin. During the study, researchers will monitor how often the CARMA technique achieves a clear resection margin and its accuracy in detecting residual polyps. They will also track the rate of incomplete resections and the time needed to apply the CARMA method for different polyp sizes. Follow-up will occur according to national guidelines, between 6 months and 5 years after the procedure, to check for polyp recurrence. Participants will be closely assessed through these procedures to help evaluate the technique's potential benefits and safety.
CONDITIONS
Brief Title
The CARMA Technique Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any polypectomy procedure with a maximum of two polyps removed per participant
- Participant is 16 years of age or older
- Participant has colonic polyps requiring removal
- Participant is available for follow-up endoscopy as scheduled
You will not qualify if you...
- Polyps less than 10mm that were removed with a clear margin greater than 1mm under endoscopic view
- Recurrence polyps at scar sites
- Polyps showing endoscopic signs of invasion
- Pedunculated polyps
- Pseudopolyps
- Participants not available for follow-up endoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Index procedure day
Participants undergo standard polyp resection followed by the CARMA technique, which involves detailed assessment of the polypectomy margins with cap-assisted magnification endoscopy.
1 procedure visit (in-person)
Duration - Between 6 months to 5 years
Participants have follow-up endoscopy procedures scheduled according to national guidelines to monitor for polyp recurrence.
1 to multiple follow-up visits depending on national guidelines
Trial Site Locations
Total: 1 location
1
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
Research Team
A
Alexander Huelsen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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