Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01942720
• Collaborator: (none)
• Enrollment: 74
• Locations: 15
• Arm: 1
• Duration (Months): 35
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure

Condition or Disease	Intervention/Treatment	Phase
Known Crohn Disease Subjects	Device: Capsule endoscopy and Ileocolonoscopy tests	N/A

Detailed Description

This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months .

Up to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\or adult subjects with known Crohn's disease

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Capsule endoscopy	Device: Capsule endoscopy and Ileocolonoscopy tests

Outcome Measures

Primary Outcome Measures

1. Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) [6 months changefrom Baseline]

   To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff

Secondary Outcome Measures

1. Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes [Baseline]

   Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline. SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific

2. Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum [6 months change from Baseline]

   Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff

3. Evaluate the Entire SB CE Scores [6 months change from Baseline]

   Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS). Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific

4. Adverse Events (AE) [6 months]

   To assess safety related to capsule retention and other adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject ages 2-75 years, inclusive

2. Subjects with a diagnosis of known Crohn disease

3. Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)

4. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment.

5. Subject or parent agrees to sign consent form

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:

1. Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE

2. Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy

3. Stricture seen on radiological exam.

4. Indeterminate Colitis

5. Ulcerative Colitis

6. Antibiotic Associated Colitis

7. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.

8. Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment

9. Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract.

10. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.

11. Subjects with known or suspected delayed gastric emptying

12. Subjects with known or suspected delayed Small bowel motility

13. Subject has any allergy or other known contraindication to the medications used in the study.

14. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception.

15. Unwillingness to use a medically accepted method of contraception throughout duration of study

16. Concurrent participation in another clinical trial using any investigational drug or device.

17. Subject has cardiac pacemaker or other implanted electromedical devices

18. Subject suffers from a life threatening condition.

19. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.

20. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Scottsdale	Arizona	United States
2	Cedars Sinai Medical Center	Los Angeles	California	United States
3	Borland-Groover Clinic	Jacksonville	Florida	United States
4	Shafran Gastroenterology Center	Winter Park	Florida	United States
5	Children's Center for Digestive Healthcare	Atlanta	Georgia	United States
6	The University of Chicago	Chicago	Illinois	United States
7	Indiana Unveresity Hospital	Indianapolis	Indiana	United States
8	Iowa Digestive Disease Center	Clive	Iowa	United States
9	University of Maryland Medical Center	Baltimore	Maryland	United States
10	Metropolitan Gastroenterology Group	Chevy Chase	Maryland	United States
11	Digestive Health Center of Michigan	Michigan	Michigan	United States
12	Atlantic Health System Morristown Memorial Pediatric GE	Morristown	New Jersey	United States
13	UNC Chapel Hill	Chapel Hill	North Carolina	United States
14	Dr. Romeo, Dayton Gastroenterology	Dayton	Ohio	United States	45440
15	Gastroenterology Associates of Tidewater	Chesapeake	Virginia	United States

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Jonathan Leighton, MD, Mayo Clinic
• Principal Investigator: Gil Melmed, MD, Cyder Cinai LA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01942720
• Other Study ID Numbers: MA-209
• First Posted: Sep 16, 2013
• Last Update Posted: May 31, 2017
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Crohn Disease

Study Results

Participant Flow

Recruitment Details	recruitment started on September 2013 and ended on July 2016 74 subjects enrolled within 15 sites in the US

Arm/Group Title	Capsule Endoscopy
Arm/Group Description	Capsule endoscopy and Ileocolonoscopy tests
Period Title: Overall Study
STARTED	74
COMPLETED	53
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Capsule Endoscopy
Arm/Group Description	Capsule endoscopy and Ileocolonoscopy tests
Overall Participants	74
Age (Count of Participants)
<=18 years	4 5.4%
Between 18 and 65 years	68 91.9%
>=65 years	2 2.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.3 (13.92)
Sex: Female, Male (Count of Participants)
Female	44 59.5%
Male	30 40.5%
Region of Enrollment (Count of Participants)
United States	74 100%

Outcome Measures

1. Primary Outcome

Title	Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)
Description	To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff
Time Frame	6 months changefrom Baseline

Outcome Measure Data

Analysis Population Description

Correlation between changes in VCE mucosal scores (Lewis and CECDEIS) and change in PGA score of CD (Crohn's Disease) activity from baseline to follow-up at 6 months; number of participants for this outcome measure includes participants with available data for PGA, SB (small bowel) Lewis score, SB CECDEIS score, respectively

Arm/Group Title	Capsule Endoscopy
Arm/Group Description	Capsule endoscopy and Ileocolonoscopy tests
Measure Participants	54
PGA score change	-0.3 (0.77)
Total SB Lewis score	-382.9 (1232.8)
Total SB CECDEIS score change	-2.7 (9.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Capsule Endoscopy
	Comments	Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-up
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.631
	Comments
	Method	Sperman test
	Comments
Method of Estimation	Estimation Parameter	Sperman correlation coeficient
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Capsule Endoscopy
	Comments	Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-up
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.882
	Comments
	Method	Sperman correlation
	Comments
Method of Estimation	Estimation Parameter	Sperman correlation coeficient
	Estimated Value	0.022
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes
Description	Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline. SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

number of participants for this outcome measure includes participants with available data for SES CD, TI Lewis score, TI CECDEIS score, respectively

Arm/Group Title	Capsule Endoscopy
Arm/Group Description	Capsule endoscopy and Ileocolonoscopy tests
Measure Participants	52
TI SES-CD score at baseline visit	3.2 (3.62)
TI Lewis score at baseline	11941.1 (1874.7)
TI CECDEIS score at baseline	14 (15.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Capsule Endoscopy
	Comments	Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visit
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Sperman correlation
	Comments
Method of Estimation	Estimation Parameter	Sperman correlation coefficient
	Estimated Value	0.735
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Capsule Endoscopy
	Comments	Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visit
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Sperman correlation
	Comments
Method of Estimation	Estimation Parameter	Sperman correlation coefficient
	Estimated Value	0.726
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum
Description	Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff
Time Frame	6 months change from Baseline

Outcome Measure Data

Analysis Population Description

number of subjects with Colonoscopy score is lower than number of subjects analyzed due to colonoscopy video malfunction. number of participants for this outcome measure includes participants with available data for TI SES CD, TI Lewis, TI CECDEIS scores, respectively

Arm/Group Title	Capsule Endoscopy
Arm/Group Description	Capsule endoscopy and Ileocolonoscopy tests
Measure Participants	45
TI SES-CD score change	-0.4 (2.88)
TI Lewis score change	-410.8 (1266.9)
TI CECDEIS score change	-3.1 (11.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Capsule Endoscopy
	Comments	Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-up
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Sperman correlation
	Comments
Method of Estimation	Estimation Parameter	Sperman correlation coefficient
	Estimated Value	0.493
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Capsule Endoscopy
	Comments	Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-up
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Sperman correlation
	Comments
Method of Estimation	Estimation Parameter	Sperman correlation coefficient
	Estimated Value	0.531
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Evaluate the Entire SB CE Scores
Description	Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS). Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific
Time Frame	6 months change from Baseline

Outcome Measure Data

Analysis Population Description

number of Lewis & CECDEIS TI score change is lower due to inability to identify TI. number of participants for this outcome measure includes participants with available data for total SB Lewis score change, TI Lewis score change, Total CECDEIS score change, TI Lewis score change, respectively

Arm/Group Title	Capsule Endoscopy
Arm/Group Description	Capsule endoscopy and Ileocolonoscopy tests
Measure Participants	49
total SB Lewis score change	-382.9 (1232.8)
TI Lewis score change	-410.8 (1266.9)
Total SB CECDEIS score change	-2.7 (9.05)
TI CECDEIS score change	-3.1 (11.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Capsule Endoscopy
	Comments	Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-up
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Sperman correlation
	Comments
Method of Estimation	Estimation Parameter	Sperman correlation coefficient
	Estimated Value	0.752
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Capsule Endoscopy
	Comments	Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-up
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Sperman correlation
	Comments
Method of Estimation	Estimation Parameter	Sperman correlation coefficient
	Estimated Value	0.785
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Adverse Events (AE)
Description	To assess safety related to capsule retention and other adverse events
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

all enrolled subjects

Arm/Group Title	Capsule Endoscopy
Arm/Group Description	Capsule endoscopy and Ileocolonoscopy tests
Measure Participants	74
Incidence of Serious Adverse Events	5
Incidence of Non-Serious Adverse Events	59
Incidence of Anticipated Adverse Events	0
Incident of Serious Unanticipated Adverse Events	5

Adverse Events

Time Frame	Adverse events data collected from subject enrollment up to end of study
Adverse Event Reporting Description	all adverse events identified on study subjects were collected from patient enrollment up to end of study duration: AE related and not related to study procedure and or product as well as anticipated and unanticipated AEs
Arm/Group Title	Capsule Endoscopy
Arm/Group Description	Capsule endoscopy and Ileocolonoscopy tests
All Cause Mortality
	Capsule Endoscopy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Capsule Endoscopy
	Affected / at Risk (%)	# Events
Total	3/74 (4.1%)
Gastrointestinal disorders
Worsening of IBD, Nausea, vomiting, diarrhea, abdominal pain	2/74 (2.7%)	2
Hepatobiliary disorders
Pancreatitis, Acute	1/74 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Asthma Excerbation, Shortness of Breath	1/74 (1.4%)	2
Other (Not Including Serious) Adverse Events
	Capsule Endoscopy
	Affected / at Risk (%)	# Events
Total	24/74 (32.4%)
Cardiac disorders
Chest Pain	1/74 (1.4%)	1
Heartburn	1/74 (1.4%)	1
Eye disorders
Detached Retina	1/74 (1.4%)	1
Gastrointestinal disorders
Abdominal Pain	2/74 (2.7%)	2
Blolating	1/74 (1.4%)	1
C-Difficile	1/74 (1.4%)	1
Crohn's Flare	1/74 (1.4%)	1
Diarrhea	4/74 (5.4%)	4
Nausea	3/74 (4.1%)	4
Rectal Urgency	1/74 (1.4%)	1
Vomiting	6/74 (8.1%)	6
General disorders
Fatigue	1/74 (1.4%)	1
Light Headed	1/74 (1.4%)	1
Questionable Right Lower Quadrant Mass	1/74 (1.4%)	1
Superficial Blood Clot Left Axilla Area	1/74 (1.4%)	1
Syncope	1/74 (1.4%)	1
Hepatobiliary disorders
Iron Deficiency Anemia	1/74 (1.4%)	1
Infections and infestations
Common Cold, cough	2/74 (2.7%)	2
Flu	2/74 (2.7%)	2
Nasal congestion	2/74 (2.7%)	2
Strep Throat	1/74 (1.4%)	1
Injury, poisoning and procedural complications
Bruise At Venipucture Site. Right Anticubital Space	1/74 (1.4%)	1
Bruised Coccyx Due To Fall	1/74 (1.4%)	1
Cyst Right Great Toe	1/74 (1.4%)	1
fell	1/74 (1.4%)	1
Hyponatremia	1/74 (1.4%)	1
Right Leg Bruising Secondary To Fall	1/74 (1.4%)	1
Metabolism and nutrition disorders
Worsening Diabetes	1/74 (1.4%)	1
Musculoskeletal and connective tissue disorders
Athralgia Of Hands And Elbows, Arthritis Flare	2/74 (2.7%)	2
back pain	1/74 (1.4%)	1
Bilateral Bursitis In Hips	1/74 (1.4%)	1
Joint pain	2/74 (2.7%)	2
Pulled Upper Back Muscle Left Side	1/74 (1.4%)	1
Renal and urinary disorders
Incontinence a Little Worse And More Often	1/74 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	1/74 (1.4%)	1
Respiratory infection	2/74 (2.7%)	2
Skin and subcutaneous tissue disorders
Mild Perianal Erythema	1/74 (1.4%)	1
Rash	4/74 (5.4%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.