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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05099432




Registration number
NCT05099432
Ethics application status
Date submitted
18/10/2021
Date registered
29/10/2021
Date last updated
15/11/2021

Titles & IDs
Public title
The CARMA Technique Study
Scientific title
The Cap-Assisted Resection Margin Assessment (CARMA) Technique After Polyp Resection: a Prospective Feasibility Study of a "Novel" Approach to Reduce Polyp Recurrence
Secondary ID [1] 0 0
75076
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyp 0 0
Colonic Sessile Serrated Lesion 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - CARMA technique

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


Treatment: Surgery: 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 code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of achieving a clear resection margin using the CARMA technique
Timepoint [1] 0 0
Established during index procedure
Secondary outcome [1] 0 0
Sensitivity and specificity of the CARMA technique for residual polyp detection
Timepoint [1] 0 0
Established during index procedure
Secondary outcome [2] 0 0
Frequency of residual polyp without CARMA assessment
Timepoint [2] 0 0
Established during index procedure
Secondary outcome [3] 0 0
Incomplete resection rate with use of CARMA technique
Timepoint [3] 0 0
Established during index procedure
Secondary outcome [4] 0 0
Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare
Timepoint [4] 0 0
Established during index procedure
Secondary outcome [5] 0 0
Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare
Timepoint [5] 0 0
Established during index procedure
Secondary outcome [6] 0 0
Residual polyp rate after CARMA technique with hot snare
Timepoint [6] 0 0
Established during index procedure
Secondary outcome [7] 0 0
Residual polyp rate after CARMA technique with cold snare
Timepoint [7] 0 0
Established during index procedure
Secondary outcome [8] 0 0
Time required for application of the CARMA technique with < 10mm
Timepoint [8] 0 0
Established during index procedure
Secondary outcome [9] 0 0
Time required for application of the CARMA technique with > 10mm
Timepoint [9] 0 0
Established during index procedure
Secondary outcome [10] 0 0
Polyp recurrence rate for < 10mm polyps
Timepoint [10] 0 0
Established during surveillance procedure (following national guidelines - between 6 months to 5 years)
Secondary outcome [11] 0 0
Polyp recurrence rate for > 10mm polyps
Timepoint [11] 0 0
Established during surveillance procedure (following national guidelines - between 6 months to 5 years)

Eligibility
Key inclusion criteria
Patients with colonic polyps will be considered following below criteria



- any polypectomy (though only a maximum of two polyps from one individual participant)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Other
Name
Princess Alexandra Hospital, Brisbane, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05099432
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexander Huelsen, MD
Address 0 0
Princess Alexandra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexander Huelsen, MD
Address 0 0
Country 0 0
Phone 0 0
+61 7 3176 2111
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05099432