Bowel Diseases, Colonic Diseases
Conditions
Keywords
Colonic Diseases, bowel diseases, large bowel diseases
Brief summary
To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.
Detailed description
Standard evaluation of subjects with suspected colon diseases includes endoscopic imaging by colonoscopy and radiology testing 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. 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 cleared by the FDA- in August 2001 for small bowel evaluation has been ingested to date by more than 1,000,000 people worldwide and is well accepted by patients and physicians as well as the professional 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. To date, several clinical studies have been conducted with Given® Diagnostic System and the PillCam™ Colon 1 capsule A pilot multicenter study is currently being conducted with a new Given® Diagnostic System and an advanced generation of the the PillCam™ Colon capsule - PillCam™ Colon 2. Capsule. The new development of Given® Diagnostic System and PillCam™ Colon 2 capsule is primarily aimed to increase sensitivity and specificity for polyp detection. Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section. This study is designed to evaluate the performance of the new version of Given® Diagnostic System and PillCam™ Colon 2 capsule in detecting patients with polyps and other colonic lesions as compared to conventional colonoscopy.
Interventions
Medical Device
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject is between the ages of 18-70 * Subject was referred to colonoscopy for at least one of the following reasons: * Colorectal cancer screening for age ≥60 * Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits for age ≥50 * Positive findings in the colon (e.g. Polyp ≥10mm) * Personal history of significant polyps( ≥6mm )that were removed at least 3 years ago (3 years and above)
Exclusion criteria
* Age \> 70 years * Subject has dysphagia or any swallowing disorder * Subject has congestive heart failure * Subject has known renal disease * Subject is not eligible for colon preparation due to the presence of underlying conditions based on the clinical judgment of the investigator * Subject has any allergy or other known contraindication to the medications used in the study * 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 judgment of the investigator * Subject has a cardiac pacemaker or other implanted electro medical device. * 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, incomplete colonoscopies due to obstructions or NSAID enteropathy, * Subject with gastrointestinal motility disorders * Subject has known delayed gastric emptying * Subject has any condition, which precludes compliance with study and/or device instructions. * Women who are either pregnant at the time of screening, 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\>70
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Detection in Patients With Colonic Polyps - Sensitivity | within 7 days | The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard. |
| Accuracy of Detection in Patients With Colonic Polyps - Specificity | within 7 days | The accuracy parameters (i.e. specificity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions | within 7 days | The diagnostic yield (%) of PCCE-2 and colonoscopy in visualizing a variety of colonic lesion excluding polyps (e.g. inflammation, diverticulosis and bleeding lesions) is provided. |
| Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | within 7 days | Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: 1. poor cleansing level (Large amount of fecal residue.) 2. fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.) 3. good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.) 4. excellent cleansing level (No more than small bits of adherent feces.) |
| Capsule Excretion Time | within 7 days | Capsule excretion time is defined as the duration of ingestion to capsule excretion time. The distribution of excretion times were categorized as follows: * capsule excreted within 4 hours * capsule excreted within 6 hours * capsule excreted within 8 hours * capsule excreted 8 hours and above |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Colon Capsule Endoscopy, Then Standard Colonoscopy Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Incomplete CE procedure | 6 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Colon Capsule Endoscopy, Then Standard Colonoscopy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 60.22 years STANDARD_DEVIATION 6.87 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 3 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Accuracy of Detection in Patients With Colonic Polyps - Sensitivity
The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.
Time frame: within 7 days
Population: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PillCam COLON | Accuracy of Detection in Patients With Colonic Polyps - Sensitivity | Patients with Polyp>= 6 mm | 89 percentage of sensiivity |
| PillCam COLON | Accuracy of Detection in Patients With Colonic Polyps - Sensitivity | Patients with Polyp, >= 10 mm | 100 percentage of sensiivity |
Primary
Accuracy of Detection in Patients With Colonic Polyps - Specificity
The accuracy parameters (i.e. specificity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.
Time frame: within 7 days
Population: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PillCam COLON | Accuracy of Detection in Patients With Colonic Polyps - Specificity | Patients with Polyp>= 6 mm | 43 percentage of specificity |
| PillCam COLON | Accuracy of Detection in Patients With Colonic Polyps - Specificity | Patients with Polyp, >= 10 mm | 66 percentage of specificity |
Secondary
Capsule Excretion Time
Capsule excretion time is defined as the duration of ingestion to capsule excretion time. The distribution of excretion times were categorized as follows: * capsule excreted within 4 hours * capsule excreted within 6 hours * capsule excreted within 8 hours * capsule excreted 8 hours and above
Time frame: within 7 days
Population: All subject who ingested the capsule were included in this analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PillCam COLON | Capsule Excretion Time | excreated <4hr | 8 Participants |
| PillCam COLON | Capsule Excretion Time | excreated >4h and <6hr | 13 Participants |
| PillCam COLON | Capsule Excretion Time | excreated >6hr ans <8hr | 8 Participants |
| PillCam COLON | Capsule Excretion Time | excreted 8hr+ | 21 Participants |
Secondary
Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions
The diagnostic yield (%) of PCCE-2 and colonoscopy in visualizing a variety of colonic lesion excluding polyps (e.g. inflammation, diverticulosis and bleeding lesions) is provided.
Time frame: within 7 days
Population: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PillCam COLON | Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions | %Patients Yield Diverticulosis | 83 percentage of yield |
| PillCam COLON | Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions | %Patients Yield Inflamatory | 4.5 percentage of yield |
| PillCam COLON | Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions | %Patients Yield Angiodysplasia | 4.5 percentage of yield |
| Standard Colonoscopy | Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions | %Patients Yield Diverticulosis | 61 percentage of yield |
| Standard Colonoscopy | Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions | %Patients Yield Inflamatory | 9 percentage of yield |
| Standard Colonoscopy | Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions | %Patients Yield Angiodysplasia | 0 percentage of yield |
Secondary
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent)
Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: 1. poor cleansing level (Large amount of fecal residue.) 2. fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.) 3. good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.) 4. excellent cleansing level (No more than small bits of adherent feces.)
Time frame: within 7 days
Population: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PillCam COLON | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Rectum | 43 percentage of participants |
| PillCam COLON | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Transverse Colon | 59 percentage of participants |
| PillCam COLON | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Overall | 61 percentage of participants |
| PillCam COLON | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Decending Colon | 83 percentage of participants |
| PillCam COLON | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Cecum | 63 percentage of participants |
| PillCam COLON | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Ascending Colon | 61 percentage of participants |
| Standard Colonoscopy | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Cecum | 88 percentage of participants |
| Standard Colonoscopy | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Overall | 86 percentage of participants |
| Standard Colonoscopy | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Rectum | 92 percentage of participants |
| Standard Colonoscopy | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Decending Colon | 86 percentage of participants |
| Standard Colonoscopy | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Transverse Colon | 82 percentage of participants |
| Standard Colonoscopy | Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) | Ascending Colon | 88 percentage of participants |