Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
Primary Purpose
Colonic Diseases
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
PillCam™ (Capsule Endoscopy)
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonic Diseases focused on measuring Colonic Diseases
Eligibility 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
Sites / Locations
- Berufsgenossenschaftliche Universitätskliniken Bergmannsheil
- Knappschaftskrankenhaus Medizinische Universitaetsklinik
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients that are indicated for colonoscopy or who are suspected or known to suffer from colonic diseases.
Outcomes
Primary Outcome Measures
Colon cleansing level score
Transit time in the different GI regions until excretion
Secondary Outcome Measures
Accuracy parameters of PCCE, compared to colonoscopy
Number of complete capsule procedure
Patient subjective assessment questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00951587
Brief Title
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
Official Title
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of the night procedure in regards to colon cleansing level and capsule excretion rate.
Detailed Description
The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography. The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, an ingestible device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System include the elimination of the need for sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.
The PillCam™ SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for small bowel evaluation has been ingested to date by more than 500,000 people worldwide and is well accepted by patients and physicians as well as the processional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. Further details of the PillCam™ Colon Capsule Endoscope (PCCE) can be found in the device description section.
This is a pilot study that is designed to evaluate the level of cleanliness and visualization of colon achieved by colon capsule endoscopy when using Night procedure regimens for preparation of the colon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases
Keywords
Colonic Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients that are indicated for colonoscopy or who are suspected or known to suffer from colonic diseases.
Intervention Type
Device
Intervention Name(s)
PillCam™ (Capsule Endoscopy)
Intervention Description
Medical Device
Primary Outcome Measure Information:
Title
Colon cleansing level score
Time Frame
within 7 days
Title
Transit time in the different GI regions until excretion
Time Frame
within 7 days
Secondary Outcome Measure Information:
Title
Accuracy parameters of PCCE, compared to colonoscopy
Time Frame
within 7 days
Title
Number of complete capsule procedure
Time Frame
within 7 days
Title
Patient subjective assessment questionnaires
Time Frame
within 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolff Schmiegel, Prof. Dr.
Organizational Affiliation
Knappschaftskrankenhaus Medizinische Universitaetsklinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berufsgenossenschaftliche Universitätskliniken Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Knappschaftskrankenhaus Medizinische Universitaetsklinik
City
Bochum
ZIP/Postal Code
44892
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
We'll reach out to this number within 24 hrs