Clinical trial NCT01480635: PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
Official title: Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonoscopy
Keywords: Incomplete Colonoscopy
Efficacy of PillCam Colon2
Lead sponsor: Bethesda Krankenhaus
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2011-11-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy

Brief summary: Purpose of study:

To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy

Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects

Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy

Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months

Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy Evaluation of distribution of excretion of capsules over time


Eligibility criteria: Inclusion Criteria:

* Subject is \>/= 18 years
* Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
* Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum \>45 min), adverse reaction to sedation requiring termination of colonoscopy

Exclusion Criteria:

* Subject has dysphagia or any swallowing disorder
* Subject has severe congestive heart failure or renal insufficiency
* Subject with high risk for capsule retention
* Subject has a cardiac pacemakers or other implanted electromedical devices
* Subject has any allergy or other contraindication to the medications used in the study
* Subject is expected to undergo MRI examination 7 days after capsule ingestion Subject has any condition, which precludes compliance with study and/or device instructions.
* Women who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
* Subject suffers from life threatening conditions
* Subject currently participating in another clinical study
* Colonoscopy had been performed by a physician who has experience of \<1000 complete colonoscopies
* Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
* Time interval between incomplete colonoscopy and capsule endoscopy \>30 days

Primary outcomes:
measure: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy
timeFrame: One week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Ev. Krankenhaus Düsseldorf
city: Düsseldorf
country: Germany
facility: Gastroenterologische Praxis
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1
city: Hamburg
country: Germany
facility: Bethesda Krankenhaus Bergedorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein
Study officials:
affiliation: Bethesda Krankenhaus Bergedorf, Hamburg, Germany
name: Martin Keuchel, Dr.
role: PRINCIPAL_INVESTIGATOR
References: