NCT03052335

Brief Summary

Main objective is to improve colorectal cancer (CRC) screening programme in the Czech Republic and decrease the disease incidence and mortality. The secondary aim is to verify the effectiveness of incorporation of the new minimally invasive device in the prevention programme.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 31, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

January 31, 2017

Last Update Submit

January 14, 2019

Conditions

Colon Cancer

Keywords

colorectal cancerscreeningcolon capsulecolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)

    1 day

Secondary Outcomes (4)

  • CCE2 accuracy for detection of advanced adenomas

    1 day

  • CCE2 accuracy for detection of colon cancer

    1 day

  • CCE2 and optical colonoscopy acceptance (special questionnaire)

    1 day

  • Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared

    1 day

Study Arms (1)

Pillcam® COLON 2 Capsule and colonoscopy

EXPERIMENTAL

Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.

Device: Pillcam® COLON 2 CapsuleProcedure: Colonoscopy

Interventions

Pillcam® COLON 2 CapsuleDEVICE

The second generation of PillCam colon capsule endoscopy (CCE-2) is 11.6 mm × 31.5 mm in size and has two imagers, that each have a 172° angle of view, allowing for almost 360° visual coverage of the colon. CCE-2 has an adaptive frame rate from 4 to 35 images per second. This means that the camera is able to capture up to 35 pictures while in motion whereas 4 images per second are captured when it is virtually stationary. During the examination the patient wears a sensor array which is attached to the abdomen and a data recorder for storage of the information generated by the ingested capsule. After the examination the data are downloaded into the workstation and a video is generated.

Pillcam® COLON 2 Capsule and colonoscopy
ColonoscopyPROCEDURE

Optical colonoscopy is the standard method for evaluating the colon

Pillcam® COLON 2 Capsule and colonoscopy

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 50 - 75 years
  • asymptomatic (no enterorhagy, weight loss or anemia)
  • signed informed consent with the study and with colonoscopy

You may not qualify if:

  • CRC high-risk group patients
  • having first degree relatives diagnosed with colorectal cancer at age ˂ 60 years
  • FAP, HNPCC and other hereditary CRC syndromes probands
  • positive personal medical history of colorectal neoplasia (advanced adenomatous polyp, colorectal cancer)
  • recent diagnostic, follow-up or preventive colonoscopy in ≤ 3 years (FOBT-positive colonoscopy, screening colonoscopy)
  • colonoscopy contraindication
  • severe acute inflammatory bowel disease
  • severe comorbidities; likely non-compliance of the patient
  • no informed consent signed (with the study and/or with colonoscopy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military University Hospital

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Colonic NeoplasmsColorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Stepan Suchanek

    Military University Hospital, Prague

    STUDY DIRECTOR

Central Study Contacts

Stepan Suchanek, MD., Ph.D.

CONTACT

973208367stepan.suchanek@uvn.cz

Michal Voska

CONTACT

773200360michal.voska@uvn.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 14, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

CZ(1)