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The CARMA Technique Study

Primary Purpose

Colonic Polyp, Colonic Sessile Serrated Lesion

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

CARMA technique

About this trial

This is an interventional treatment trial for Colonic Polyp

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Princess Alexandra HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CARMA Technique

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of achieving a clear resection margin using the CARMA technique

Secondary Outcome Measures

Sensitivity and specificity of the CARMA technique for residual polyp detection

Frequency of residual polyp without CARMA assessment

Incomplete resection rate with use of CARMA technique

Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare

Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare

Residual polyp rate after CARMA technique with hot snare

Residual polyp rate after CARMA technique with cold snare

Time required for application of the CARMA technique with < 10mm

Time required for application of the CARMA technique with > 10mm

Polyp recurrence rate for < 10mm polyps

Polyp recurrence rate for > 10mm polyps

Full Information

NCT ID

NCT05099432

First Posted

October 18, 2021

Last Updated

November 5, 2021

Sponsor

Princess Alexandra Hospital, Brisbane, Australia

1. Study Identification

Unique Protocol Identification Number

NCT05099432

Brief Title

The CARMA Technique Study

Official Title

The Cap-Assisted Resection Margin Assessment (CARMA) Technique After Polyp Resection: a Prospective Feasibility Study of a "Novel" Approach to Reduce Polyp Recurrence

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 2021 (Anticipated)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Princess Alexandra Hospital, Brisbane, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Polyp, Colonic Sessile Serrated Lesion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CARMA Technique

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

CARMA technique

Intervention Description

Once standard polyp resection and assessment of the polypectomy site without magnification is completed, the CARMA technique will be applied. This will involve an assessment of the entire polypectomy margin using cap assisted magnification endoscopy with the ability to also use NBI (at the endoscopist's discretion) and documentation of any residual polyp noted.

Primary Outcome Measure Information:

Title

Rate of achieving a clear resection margin using the CARMA technique

Time Frame