Cold Polypectomy Site Study | NCT02205125

Studies
Cold Polypectomy Site Study

NCT02205125

Sponsor

Professor Michael Bourke

Status

Completed

Last Update Posted

Mar 23, 2021Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Colonic Polyps

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 26, 2014

First Submission Date that Met QC Criteria

Jul 29, 2014

First Posted Date

Jul 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2021

Last Update Posted Date

Mar 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Michael Bourke, Director of Endoscopy, Westmead Hospital, Sydney, Australia, Western Sydney Local Health DistrictSponsor-Investigator

Lead Sponsor

Professor Michael BourkeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional method for removal however the snared area after removal can occasionally appear uneven raising the possibility that complete removal has not occurred. The significance of this irregularity has not be studied. This study aims to separately sample the irregular area and determine the constituents while recording how frequently this occurs during routine colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue and do not represent polyp tissue left behind.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

88Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and constituents of stalk projections in cold snare polypectomy sites	Biopsy of post cold snare polypectomy stalk to determine constituents of stalk. This was reviewed 14 days following the procedure.	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing colonoscopy with at least one polyp identified where polypectomy is planned.

Exclusion Criteria:

Age < 18 years
Patients where polypectomy is not planned to be undertaken (patients scheduled for diagnostic colonoscopy only).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing colonoscopy at a tertiary endoscopy unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Bourke, MBBS, FRACP	WSLHD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Westmead Hospital Endoscopy Unit		Sydney	New South Wales	2145	Australia

Condition Browse Module

MeSH Terms

ID	Term
D003111	Colonic Polyps
D011127	Polyps

Ancestor Terms

ID	Term
D007417	Intestinal Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

All polypectomy specimens were submitted for histopathological assessment as per clinical practice. The biopsy samples from the irregular areas were also submitted in the same fashion. All specimens are stored as per current clinical practice.