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Colonic PolypNCT05099432

The CARMA Technique Study

A study testing CARMA technique in people with Colonic Polyp and Colonic Sessile Serrated Lesion, run by Princess Alexandra Hospital, Brisbane, Australia at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
CARMA technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteAustralia
Study dates
Nov 2021to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander Huelsen, MD contact

+61 7 3176 2111

alexander.huelsenkatz@health.qld.gov.au

Australia1 site, 1 recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Alexander Huelsen, MD, +61 7 3176 2111, alexander.huelsenkatz@health.qld.gov.au

    Alexander Huelsen

    Recruiting

Other trials in Australia

About this 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

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.

Being tested
CARMA technique
Medical subject headings
Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CARMA techniqueProcedure or surgery

    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.

Study groups in NCT05099432
Study groupRoleWhat they receive
CARMA TechniqueExperimentalAll included participants undergo polyp resection using standard of care polypectomy techniques, followed by the CARMA technique
Receives: Procedure: CARMA technique

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Established during index procedure

Secondary outcomes (11)

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

    Measured: Established during index procedure

  2. Frequency of residual polyp without CARMA assessment

    Measured: Established during index procedure

  3. Incomplete resection rate with use of CARMA technique

    Measured: Established during index procedure

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

    Measured: Established during index procedure

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

    Measured: Established during index procedure

  6. Residual polyp rate after CARMA technique with hot snare

    Measured: Established during index procedure

  7. Residual polyp rate after CARMA technique with cold snare

    Measured: Established during index procedure

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

    Measured: Established during index procedure

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

    Measured: Established during index procedure

  10. Polyp recurrence rate for < 10mm polyps

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

  11. Polyp recurrence rate for > 10mm polyps

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study startNov 2021 (estimated)
  3. Primary completionMay 2023 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099432
Sponsor's protocol ID
75076
Status last verified
Nov 2021
First submitted
18 Oct 2021
Last updated
15 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CARMA technique in people with Colonic Polyp and Colonic Sessile Serrated Lesion, run by Princess Alexandra Hospital, Brisbane, Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Huelsen, MD (+61 7 3176 2111, alexander.huelsenkatz@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of achieving a clear resection margin using the CARMA technique (time frame: Established during index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05099432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

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