The CARMA Technique Study

Not Applicable

Recruiting

• Conditions: Colonic Polyp; Colonic Sessile Serrated Lesion
• Interventions: Procedure: CARMA technique

• Registration Number: NCT05099432
• Lead Sponsor: Princess Alexandra Hospital, Brisbane, Australia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Status Verified: 2021-11
• Study Start: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-15
• Primary Completion: 2023-05
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of achieving a clear resection margin using the CARMA technique	Established during index procedure

Secondary Outcome Measures

Name	Time	Method
Frequency of residual polyp without CARMA assessment	Established during index procedure
Sensitivity and specificity of the CARMA technique for residual polyp detection	Established during index procedure
Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare	Established during index procedure
Residual polyp rate after CARMA technique with hot snare	Established during index procedure
Residual polyp rate after CARMA technique with cold snare	Established during index procedure
Incomplete resection rate with use of CARMA technique	Established during index procedure
Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare	Established during index procedure
Time required for application of the CARMA technique with < 10mm	Established during index procedure
Time required for application of the CARMA technique with > 10mm	Established during index procedure
Polyp recurrence rate for < 10mm polyps	Established during surveillance procedure (following national guidelines - between 6 months to 5 years)
Polyp recurrence rate for > 10mm polyps	Established during surveillance procedure (following national guidelines - between 6 months to 5 years)

Trial Locations

Locations (1)

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia