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Clinical Trials/NCT02303756
NCT02303756CompletedNot Applicable

Colonic Capsule Endoscopy (CCE) for Screening of Neoplasm's

Odense University Hospital1 site in 1 country250 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
250
Locations
1
Primary Endpoint
Identification of neoplasia

Study Overview

Brief Summary

The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection of neoplasms compared to conventional colonoscopy in persons participating in the Danish screening program for colorectal cancer with a positive fecal occult blood with the colonoscopy being the gold standard.

Detailed Description

Participants will be recruited from the screening program, and are living on the main island of Funen. Persons with a positive FOBT who have been offered and have accepted a colonoscopy will be contacted by telephone and informed about the project by the project nurse.

The persons who accept participation and meet the inclusion criteria will be contacted by the study nurse for scheduling the capsule endoscopy according to the planned colonoscopy, which has to bee within 9-13 days after the result of the FOBT test.

The nurse will instruct the person to take the standard colon preparation 2 days before the colonoscopy, and stay from solid food until after the colonoscopy has been performed according to standard procedure. Thus the period with food-restrictions has to be extended by one day. A visit by the home services nurse the day before the colonoscopy will be arranged. The nurse will assist and supervise the intake of the video capsule and assists with the attachment of the monitor in a belt around the person's belly. Afterwards the questionnaire 1 (appendix 1) will be fulfilled by the patient with assistance from the nurse.

When the capsule has passed anus the monitoring equipment must be disarmed by the patient and stored according to the instructions. The patient will bring the recorder to the hospital the following day and deliver it to the study nurse, who will take care of data-transmission to the institute in Hamburg. After the colonoscopy and recovery period, the patient and the project nurse will fulfill the 2. questionnaire (appendix 2) and the colonoscopist will fulfill a standard report on the findings and treatment at colonoscopy (appendix 3), which will be added to the electronic database by the project secretary. The results form the colonoscopy will be the only information, that will be retrieved form the patients record.

Trained specialists in the Diagnostic Centre in Hamburg will perform the evaluation of the CCE and the data will be entered in a standard diagnostic report (appendix 4). The Diagnostic Centre will not have access to the results of the colonoscopy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Positive feaecal occult bleeding test at screening

Exclusion Criteria

  • •Previous gastrointestinal surgery except for appendectomy
  • •Known inflammatory bowel disease including Chrohn's disease and ulcerative colitis
  • •An ostomy
  • •Symptoms on bowel obstruction (recurrent abdominal pain, constipation or vomiting within the last 3 months)
  • •Vomiting in connection with the bowel emptying procedure

Arms & Interventions

Pillcam® COLON Capsule

Experimental

Detection of neoplastic lesions in colon and rectum compared to colonoscopy

Intervention: Pillcam® COLON Capsule (Device)

Outcomes

Primary Outcomes

Identification of neoplasia

Time Frame: One week after examination

Compared to colonoscopy

Secondary Outcomes

  • Completion rate(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Niels Qvist

Professor

Odense University Hospital

Study Sites (1)

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