Clinical Trials Logo
  1. Home
  2. Colonic Diseases
  3. NCT00604292

Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) Preparation and Procedure

Colonic Diseases Clinical Trial

Official title:
Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure

Clinical Trial Summary

To evaluate the effect of a modified preparation and procedure on colon cleansing level

Clinical Trial Description

The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy. The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable 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 conscious 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 300,000 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 compare capsule colonoscopy and colonoscopy procedures with respect to colon cleansing level and progression of colon capsule. Furthermore, the two procedures will be compared in regards to the detection of colon abnormalities. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00604292
Study type Observational
Source Medtronic - MITG
Contact
Status Completed
Phase
Start date June 2007
Completion date March 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Terminated NCT01119027 - Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills N/A
Completed NCT01063231 - Evaluation of PillCam™ Colon 2 in Visualization of the Colon Phase 3
Completed NCT04074577 - Computer Aided Detection, Tandem Colonoscopy Study N/A
Not yet recruiting NCT04087824 - Deep Learning Algorithm for Recognition of Colonic Segments. N/A
Completed NCT03559543 - Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma Phase 2
Terminated NCT02503631 - Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Completed NCT01600209 - Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing N/A
Completed NCT01260168 - Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies N/A
Completed NCT00604162 - PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon Phase 3
Recruiting NCT04598880 - Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing Phase 4
Completed NCT01738425 - A Clinical Phase I Study on GIC-1001 in Healthy Volunteers Phase 1
Completed NCT04080843 - Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients Phase 2
Terminated NCT04644315 - A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors Phase 2
Completed NCT02291445 - Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study Phase 2
Completed NCT03037385 - Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03139942 - Optical Polyp Testing for In Vivo Classification N/A
Completed NCT04263818 - Endoscopist and Endoscope Motions During Colonoscopy N/A
Recruiting NCT05923918 - A Study to Evaluate Safety and Efficacy of PBK_M2101 Phase 3
Completed NCT02647866 - Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis Phase 2