The CARMA Technique Study

Princess Alexandra Hospital

Status: Enrolling

Conditions: Colonic Polyp; Colonic Sessile Serrated Lesion

Treatments: Procedure: CARMA technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05099432

75076

Details and patient eligibility

About

Colonoscopic removal of polyps is an important and well-established tool in the prevention of colorectal cancers. However, high polyp recurrence rates after endoscopic resection, with resultant development of interval cancers, remains a problem; this most commonly stems from unrecognised incomplete polyp resection. Thus, a standardised endoscopic technique is needed that will allow endoscopists to consistently achieve a clear margin of resection. The investigators believe the Cap Assisted Resection Margin Assessment (CARMA) technique will address this problem. This novel technique focuses on a standardised assessment of the resection margin after endoscopic polypectomy utilising available standard high-definition video endoscopes with imaging features including narrow band imaging (NBI) and magnification endoscopy.

Enrollment: 60 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients with colonic polyps will be considered following below criteria

Inclusion Criteria:

• any polypectomy (though only a maximum of two polyps from one individual participant)

Exclusion Criteria:

• polyps less than 10mm which were resected under endoscopic view with a definite > 1mm clear margin
• scar site recurrence polyps
• polyps with endoscopic evidence of invasion
• pedunculated polyps
• pseudopolyps
• participants who will not be available for follow up endoscopy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

CARMA Technique

Experimental group

Description:

All included participants undergo polyp resection using standard of care polypectomy techniques, followed by the CARMA technique

Treatment:

Procedure: CARMA technique