Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00951587
• Date of registration: 02/08/2009
• Primary sponsor: Given Imaging Ltd.
• Public title: Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
• Scientific title: Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
• Date of first enrolment: February 2008
• Target sample size: 49
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00951587
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

Germany

Contacts

• Name: Wolff Schmiegel, Prof. Dr.
• Affiliation: Knappschaftskrankenhaus Medizinische Universitaetsklinik

Key inclusion & exclusion criteria

Inclusion criteria:

- Subject is between the ages of 50-75 years and has an indication to undergo
colonoscopy: At least 75% of total cases OR

- Subject is 18-50 suspected/known to suffer from large bowel disease and was
clinically referred for colonoscopy (e.g. rectal bleeding, melena, positive FOBT,
recent change of bowel habits, CRC screening, UC, positive findings on a GI
radiographic study - no more than 25% of total cases

Exclusion criteria

- Subject has dysphagia or any swallowing disorder

- Subject has severe Congestive heart failure (NYHA II or IV)

- Subject has renal insufficiency

- Subject has had prior abdominal surgery of the gastrointestinal tract other than
uncomplicated procedures that would be unlikely to lead to bowel obstruction based on
the clinical judgement of the investigator

- Subject has a cardiac pacemaker or other implanted electromedical device.

- Subject has any allergy or other known contraindication to the medications used in
the study

- Subject is expected to undergo MRI examination within 7 days after ingestion of the
capsule.

- Subject with any condition believed to have an increased risk for capsule retention
such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID
enteropathy,

- Subject has any condition, which precludes compliance with study and/or device
instructions.

- Women who are either pregnant or nursing at the time of screening, who intend to be
during the study period, or are of child-bearing potential and do not practice
medically acceptable methods of contraception.

- Subject suffers from life threatening conditions

- Subject currently participating in another clinical study



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colonic Diseases

Intervention(s)

Device: PillCam™ (Capsule Endoscopy)

Primary Outcome(s)

Colon cleansing level score [Time Frame: within 7 days]

Transit time in the different GI regions until excretion [Time Frame: within 7 days]

Secondary Outcome(s)

Accuracy parameters of PCCE, compared to colonoscopy [Time Frame: within 7 days]

Number of complete capsule procedure [Time Frame: within 7 days]

Patient subjective assessment questionnaires [Time Frame: within 7 days]

Secondary ID(s)

MA-104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors