Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05099432

The CARMA Technique Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Colonic Polyp Colonic Polyps Colonic Sessile Serrated Lesion Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARMA technique

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.

Primary outcomes

  1. Rate of achieving a clear resection margin using the CARMA technique

    Time frame: Established during index procedure

Secondary outcomes

  1. Sensitivity and specificity of the CARMA technique for residual polyp detection

    Time frame: Established during index procedure

  2. Frequency of residual polyp without CARMA assessment

    Time frame: Established during index procedure

  3. Incomplete resection rate with use of CARMA technique

    Time frame: Established during index procedure

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

    Time frame: Established during index procedure

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

    Time frame: Established during index procedure

  6. Residual polyp rate after CARMA technique with hot snare

    Time frame: Established during index procedure

  7. Residual polyp rate after CARMA technique with cold snare

    Time frame: Established during index procedure

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

    Time frame: Established during index procedure

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

    Time frame: Established during index procedure

  10. Polyp recurrence rate for < 10mm polyps

    Time frame: Established during surveillance procedure (following national guidelines - between 6 months to 5 years)

  11. Polyp recurrence rate for > 10mm polyps

    Time frame: Established during surveillance procedure (following national guidelines - between 6 months to 5 years)

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Princess Alexandra Hospital, Brisbane, Australia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Oct 29, 2021
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.