NCT03501849

Brief Summary

During colonoscopy, the endoscopist will document prospectively all polyps detected and note the size, location and morphology. Polyps of 4-20 mm will be removed only in accordance with the method the cold snare. Afterwards, the remaining tissues could be observed with an imaging technology called Optivista with an injection of 10-50 ml of saline solution (if required) to improve visibility of the tissues. The endoscopist will continue to remove the remaining polyp tissue (with a snare or forceps) until there are no more visible polyp tissues. Biopsies from the polyp resection site will be sent to the laboratory for analysis to confirm the complete resection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
Last Updated

February 4, 2021

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

April 10, 2018

Last Update Submit

February 2, 2021

Conditions

Colorectal CancerColon Adenoma

Keywords

Cancer preventionCancer detectionColonoscopyPolypectomyCold Snare

Outcome Measures

Primary Outcomes (1)

  • Incomplete resection rate (in percentage)

    Incomplete resection rate as defined by any adenomatous polyp tissue found in at least one marginal biopsies

    2 years

Secondary Outcomes (2)

  • Number of immediate bleeding complication (numerical)

    2 years

  • Number of delayed bleeding complications (numerical)

    2 years

Study Arms (1)

Polypectomy using a cold snare

EXPERIMENTAL

Polypectomy by cold-snare technique

Device: Polypectomy using a cold snare

Interventions

Polypectomy using a cold snareDEVICE

Polypectomy by cold-snare technique

Polypectomy using a cold snare

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Age 45 to 80 years
  • Indication for full colonoscopy

You may not qualify if:

  • Known inflammatory bowel disease
  • Active colitis
  • Coagulopathy
  • Familial polyposis syndrome
  • Poor general health defined as an ASA class \> 3
  • Emergency colonoscopies defined as patients with evidence of hemodynamic instability and/or ongoing active GI bleeding and/or intensive care requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada

Location

Related Publications (1)

  • von Renteln D, Djinbachian R, Benard F, Barkun AN, Bouin M, Bouchard S, Deslandres E, Panzini B, Sidani S, Leduc R, Jobse BC, Pohl H. Incomplete resection of colorectal polyps of 4-20 mm in size when using a cold snare, and its associated factors. Endoscopy. 2023 Oct;55(10):929-937. doi: 10.1055/a-1978-3277. Epub 2022 Nov 14.

    PMID: 36377124DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Daniel von Renteln, MD, PhD

    Centre Hospitalier Universitaire de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Study Start

May 15, 2018

Primary Completion

March 4, 2019

Study Completion

March 4, 2019

Last Updated

February 4, 2021

Record last verified: 2018-04

Locations

CA(1)