Safety and Efficacy of Endocuff-assisted Colonoscopy for... | NCT02374515

Studies
Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.

NCT02374515

Sponsor

University of Naples

Status

Completed

Last Update Posted

Jun 15, 2016Estimated

Enrollment

275Actual

Phase

Not Applicable

Conditions

Adenomatous Polyps

Interventions

EndoCuff-assisted colonoscopy
Standard Colonoscopy

Countries

Italy

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

Jun 2016

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

Feb 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Feb 23, 2015

First Submission Date that Met QC Criteria

Feb 26, 2015

First Posted Date

Feb 27, 2015Estimated

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

Jun 13, 2016

Last Update Posted Date

Jun 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giovanni Domenico De Palma, Full Professor of Surgery, Federico II UniversityPrincipal Investigator

Lead Sponsor

University of NaplesOTHER

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

This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.

Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.

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

275Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endocuff assisted Colonoscopy	Active Comparator	Endocuff assisted Colonoscopy	Device: EndoCuff-assisted colonoscopy
Standard Colonoscopy	Active Comparator	Standard colonoscopy	Device: Standard Colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EndoCuff-assisted colonoscopy	Device	Adenoma detection rate	Endocuff assisted Colonoscopy

Measure	Description	Time Frame
adenoma detection rate		20 min.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colonoscopy: Screening , Surveillance, Diagnostic

Exclusion Criteria:

Pregnancy
age<18 years
age > 80 years
known colonic strictures
chronic inflammatory bowel disease
active inflammation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giovanni D. De Palma, MD	Federico II University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Naples Federico II		Naples		80131	Italy

Condition Browse Module

MeSH Terms

ID	Term
D018256	Adenomatous Polyps

Ancestor Terms

ID	Term
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided