Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID05099432

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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Surveillance

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

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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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