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The CARMA Technique Study

NCT ID: NCT05099432

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2026-11-30

Brief Summary

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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 problemÍž 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

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Conditions

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Colonic Polyp Colonic Sessile Serrated Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CARMA Technique

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

Group Type EXPERIMENTAL

CARMA technique

Intervention Type PROCEDURE

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.

Interventions

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CARMA technique

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Alexandra Hospital, Brisbane, Australia

OTHER

Sponsor Role lead

Responsible Party

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Alexander Huelsen

Interventional Gastroenterologist, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Huelsen, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Alexandra Hospital

Locations

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Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Alexander Huelsen, MD

Role: CONTACT

Phone: +61 7 3176 2111

Email: [email protected]

Facility Contacts

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Alexander Huelsen, MD

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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75076

Identifier Type: -

Identifier Source: org_study_id