Prospective Randomized Comparison of Cold Snare Polypecto... | NCT00763425

Studies
Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy

NCT00763425

Sponsor

Showa Inan General Hospital

Status

Completed

Last Update Posted

Nov 18, 2015Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

cold polypectomy
conventional polypectomy

Countries

Japan

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

Nov 2015

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

Sep 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Sep 29, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 1, 2008Estimated

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

Nov 17, 2015

Last Update Posted Date

Nov 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Akira Horiuchi, Digestive Disease Center, Showa Inan General HospitalPrincipal Investigator

Lead Sponsor

Showa Inan General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps.

Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Procedure: cold polypectomy
2	Active Comparator		Procedure: conventional polypectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cold polypectomy	Procedure	The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete removal rate of colorectal polyps		two weeks after each polypectomy

Secondary Outcomes

Measure	Description	Time Frame
Complication rate		two weeks after each polypectomy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Men or women between 20 and 100 years of age

Exclusion Criteria:

Exclusion criteria include age less than 20 years old
Pregnant, American Society of Anesthesiologists class III and IV
Overweight (body weight > 100 kg)
Allergic to the drugs used or its components (soybeans or eggs)
Poor bowel preparation or post-colorectal surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Showa Inan General hospital		Komagane	Nagano	399-4191	Japan

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D003111	Colonic Polyps

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided