NCT02331836

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
561

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

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

January 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

4 years

First QC Date

January 2, 2015

Last Update Submit

February 10, 2019

Conditions

Colorectal PolypsColorectal Adenomas

Keywords

adenoma detection ratepolyp detection ratewithdrawal timecoecal and ileum intubation rate

Outcome Measures

Primary Outcomes (2)

  • 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 (8)

  • Bowel preparation result

    one day

  • Coecum intubation rate

    one year

  • Ileum intubation rate

    one year

  • Coecum intubation time

    one day

  • withdrawal time

    one day

  • +3 more secondary outcomes

Study Arms (3)

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

Arc Endocuff (AEC 110, 120, 130, 140)DEVICE
Arc Endocuff (AEC 110, 120, 130, 140)
CapDEVICE

Olympus Disposable distal attachment 15mm diameter, 4mm depth

Cap
Standard colonoscopeDEVICE
Standard Colonoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

University Medical Center Göttingen

Göttingen, 37075, Germany

Location

HELIOS St. Marienberg Klinik Helmstedt

Helmstedt, Germany

Location

HELIOS Albert-Schweitzer-Klinik

Northeim, 37154, Germany

Location

HELIOS Medical Center Siegburg

Siegburg, Germany

Location

Wroclaw Medical University

Wroclaw, 50-556, Poland

Location

MeSH Terms

Interventions

Contraceptive Devices, Female

Intervention Hierarchy (Ancestors)

Contraceptive DevicesEquipment and Supplies

Study Officials

  • Tobias Meister, Prof. Dr.med.

    Helios Albert-Schweitzer-Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Tobias Meister

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 6, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

PL(1)DE(5)