Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440791
Status:
TERMINATED
Last Update Posted:
2019-07-31
First Post:
2007-02-26
Brief Title:
Evaluation of the PillCam Colon Capsule Endoscopy PCCE in the Visualization of the Colon
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
Evaluation of the PillCam Colon Capsule Endoscopy PCCE in the Visualization of the Colon
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multi-center prospective cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy This study aims a To evaluate and compare the accuracy of PillCam Colon capsule endoscopy PCCE with standard colonoscopy This study will evaluate the safety of PillCam Colon capsule endoscopy PCCE
Detailed Description:
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 This multi-center prospective cohort study will evaluate the performance of PCCE in visualizing the colon Up to 394 subjects will participate in this study All subjects to be enrolled will be appropriate candidates for standard colonoscopy based on their clinical indication
Each subject will undergo PCCE All generated PCCE RAPID videos will be reviewed by blinded PCCE reading physicians All readers experienced in PillCam SB will have undergone standardized training and passed a qualification test specific to reading and interpreting PCCE videos Training will be done by reading at least 5 cases to demonstrate proficiency in interpretation of PCCE PCCE results will be compared with that of a colonoscopy procedure
Following PCCE procedure standard colonoscopy will be performed by a colonoscopist blinded to the results of the PCCE The colonoscopist will be unblinded during the standard colonoscopy procedure at three locations on withdrawal of the colonoscope
Primary Endpoint - Accuracy parameters sensitivity specificity NPV PPV of PCCE compared to standard colonoscopy
Number type and severity of adverse events with both PCCE and standard colonoscopy
Each subject will undergo PCCE All generated PCCE RAPID videos will be reviewed by blinded PCCE reading physicians All readers experienced in PillCam SB will have undergone standardized training and passed a qualification test specific to reading and interpreting PCCE videos Training will be done by reading at least 5 cases to demonstrate proficiency in interpretation of PCCE PCCE results will be compared with that of a colonoscopy procedure
Following PCCE procedure standard colonoscopy will be performed by a colonoscopist blinded to the results of the PCCE The colonoscopist will be unblinded during the standard colonoscopy procedure at three locations on withdrawal of the colonoscope
Primary Endpoint - Accuracy parameters sensitivity specificity NPV PPV of PCCE compared to standard colonoscopy
Number type and severity of adverse events with both PCCE and standard colonoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None