Endocuff-assisted Versus Cap-assisted Versus Standard Col... | NCT02331836

Studies
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

NCT02331836

Sponsor

Helios Albert-Schweitzer-Klinik Northeim

Status

Completed

Last Update Posted

Feb 12, 2019Actual

Enrollment

561Actual

Phase

Not Applicable

Conditions

Colorectal Polyps
Colorectal Adenomas

Interventions

Arc Endocuff (AEC 110, 120, 130, 140)
Cap
Standard colonoscope

Countries

Germany
Poland

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

Feb 2019

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 2015Actual

Primary Completion Date

Feb 1, 2019Actual

Completion Date

Feb 1, 2019Actual

First Submitted Date

Jan 2, 2015

First Submission Date that Met QC Criteria

Jan 5, 2015

First Posted Date

Jan 6, 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

Feb 10, 2019

Last Update Posted Date

Feb 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tobias Meister, Prof. Dr. med. Tobias Meister, Helios Albert-Schweitzer-Klinik NortheimPrincipal Investigator

Lead Sponsor

Helios Albert-Schweitzer-Klinik NortheimOTHER

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

Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

Detailed Description

The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

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

561Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arc Endocuff (AEC 110, 120, 130, 140)	Active Comparator	Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope	Device: Arc Endocuff (AEC 110, 120, 130, 140)
Cap	Active Comparator	Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope	Device: Cap
Standard Colonoscope	Active Comparator	Standard colonoscopy without any additional device	Device: Standard colonoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arc Endocuff (AEC 110, 120, 130, 140)	Device		Arc Endocuff (AEC 110, 120, 130, 140)
Cap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoma detection rate	Proportion of patients having at least one adenoma	1 year
Polyp detection rate	Proportion of patients having at least one adenoma	1 year

Secondary Outcomes

Measure	Description	Time Frame
Bowel preparation result		one day
Coecum intubation rate		one year
Ileum intubation rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colonoscopy independent from indication
Age ≥ 18
Patient is able to provide informed consent for the procedure

Exclusion Criteria:

Inflammatory Bowel Disease stenosis
Pregnant of nursing patient
Acute diverticulitis
Active Inflammatory Bowel Disease
Age ≤ 18
Coagulation disorder (INR>1.4 , Thrombocytes < 50000/µl)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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

Name	Affiliation	Role
Tobias Meister, Prof. Dr.med.	Helios Albert-Schweitzer-Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Muenster		Münster	North Rhine-Westphalia	48149	Germany
University Medical Center Göttingen

Intervention Browse Module

MeSH Terms

ID	Term
D003274	Contraceptive Devices, Female

Ancestor Terms

ID	Term
D003273	Contraceptive Devices
D004864	Equipment and Supplies

Browse Leaves

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Browse Branches

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