Trial Outcomes & Findings for Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects (NCT NCT01942720)

NCT ID: NCT01942720

Last Updated: 2017-05-31

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

6 months changefrom Baseline

Results posted on

2017-05-31

Participant Flow

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

Participant milestones

Participant milestones
Measure	Capsule Endoscopy Capsule endoscopy and Ileocolonoscopy tests
Overall Study STARTED	74
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capsule Endoscopy n=74 Participants Capsule endoscopy and Ileocolonoscopy tests
Age, Categorical <=18 years	4 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Age, Continuous	37.3 years STANDARD_DEVIATION 13.92 • n=93 Participants
Sex: Female, Male Female	44 Participants n=93 Participants
Sex: Female, Male Male	30 Participants n=93 Participants
Region of Enrollment United States	74 Participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months changefrom Baseline

Population: 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

Outcome measures

Outcome measures
Measure	Capsule Endoscopy n=54 Participants Capsule endoscopy and Ileocolonoscopy tests
Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) PGA score change	-0.3 units on a scale Standard Deviation 0.77
Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) Total SB Lewis score	-382.9 units on a scale Standard Deviation 1232.8
Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) Total SB CECDEIS score change	-2.7 units on a scale Standard Deviation 9.05

SECONDARY outcome

Timeframe: Baseline

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

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

Outcome measures

Outcome measures
Measure	Capsule Endoscopy n=52 Participants Capsule endoscopy and Ileocolonoscopy tests
Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes TI SES-CD score at baseline visit	3.2 units on a scale Standard Deviation 3.62
Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes TI Lewis score at baseline	11941.1 units on a scale Standard Deviation 1874.7
Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes TI CECDEIS score at baseline	14 units on a scale Standard Deviation 15.51

SECONDARY outcome

Timeframe: 6 months change from Baseline

Population: 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

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

Outcome measures

Outcome measures
Measure	Capsule Endoscopy n=45 Participants Capsule endoscopy and Ileocolonoscopy tests
Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum TI SES-CD score change	-0.4 units on a scale Standard Deviation 2.88
Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum TI Lewis score change	-410.8 units on a scale Standard Deviation 1266.9
Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum TI CECDEIS score change	-3.1 units on a scale Standard Deviation 11.55

SECONDARY outcome

Timeframe: 6 months change from Baseline

Population: 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

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

Outcome measures

Outcome measures
Measure	Capsule Endoscopy n=49 Participants Capsule endoscopy and Ileocolonoscopy tests
Evaluate the Entire SB CE Scores total SB Lewis score change	-382.9 units on a scale Standard Deviation 1232.8
Evaluate the Entire SB CE Scores TI Lewis score change	-410.8 units on a scale Standard Deviation 1266.9
Evaluate the Entire SB CE Scores Total SB CECDEIS score change	-2.7 units on a scale Standard Deviation 9.05
Evaluate the Entire SB CE Scores TI CECDEIS score change	-3.1 units on a scale Standard Deviation 11.55

SECONDARY outcome

Timeframe: 6 months

Population: all enrolled subjects

To assess safety related to capsule retention and other adverse events

Outcome measures

Outcome measures
Measure	Capsule Endoscopy n=74 Participants Capsule endoscopy and Ileocolonoscopy tests
Adverse Events (AE) Incidence of Serious Adverse Events	5 AE incidents
Adverse Events (AE) Incidence of Non-Serious Adverse Events	59 AE incidents
Adverse Events (AE) Incidence of Anticipated Adverse Events	0 AE incidents
Adverse Events (AE) Incident of Serious Unanticipated Adverse Events	5 AE incidents

Adverse Events

Capsule Endoscopy

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capsule Endoscopy n=74 participants at risk Capsule endoscopy and Ileocolonoscopy tests
Gastrointestinal disorders Worsening of IBD, Nausea, vomiting, diarrhea, abdominal pain	2.7% 2/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
Respiratory, thoracic and mediastinal disorders Asthma Excerbation, Shortness of Breath	1.4% 1/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
Hepatobiliary disorders Pancreatitis, Acute	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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

Other adverse events

Other adverse events
Measure	Capsule Endoscopy n=74 participants at risk Capsule endoscopy and Ileocolonoscopy tests
Gastrointestinal disorders Abdominal Pain	2.7% 2/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
Respiratory, thoracic and mediastinal disorders Asthma	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Musculoskeletal and connective tissue disorders Athralgia Of Hands And Elbows, Arthritis Flare	2.7% 2/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
Musculoskeletal and connective tissue disorders back pain	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Musculoskeletal and connective tissue disorders Bilateral Bursitis In Hips	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Gastrointestinal disorders Blolating	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Injury, poisoning and procedural complications Bruise At Venipucture Site. Right Anticubital Space	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Injury, poisoning and procedural complications Bruised Coccyx Due To Fall	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Gastrointestinal disorders C-Difficile	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Cardiac disorders Chest Pain	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Infections and infestations Common Cold, cough	2.7% 2/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
Gastrointestinal disorders Crohn's Flare	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Injury, poisoning and procedural complications Cyst Right Great Toe	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Eye disorders Detached Retina	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Gastrointestinal disorders Diarrhea	5.4% 4/74 • Number of events 4 • Adverse events data collected from subject enrollment up to end of study 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
General disorders Fatigue	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Injury, poisoning and procedural complications fell	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Infections and infestations Flu	2.7% 2/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
Cardiac disorders Heartburn	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Injury, poisoning and procedural complications Hyponatremia	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Renal and urinary disorders Incontinence a Little Worse And More Often	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Hepatobiliary disorders Iron Deficiency Anemia	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Musculoskeletal and connective tissue disorders Joint pain	2.7% 2/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
General disorders Light Headed	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Skin and subcutaneous tissue disorders Mild Perianal Erythema	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Infections and infestations Nasal congestion	2.7% 2/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
Gastrointestinal disorders Nausea	4.1% 3/74 • Number of events 4 • Adverse events data collected from subject enrollment up to end of study 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
Musculoskeletal and connective tissue disorders Pulled Upper Back Muscle Left Side	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
General disorders Questionable Right Lower Quadrant Mass	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Skin and subcutaneous tissue disorders Rash	5.4% 4/74 • Number of events 4 • Adverse events data collected from subject enrollment up to end of study 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
Gastrointestinal disorders Rectal Urgency	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Respiratory, thoracic and mediastinal disorders Respiratory infection	2.7% 2/74 • Number of events 2 • Adverse events data collected from subject enrollment up to end of study 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
Injury, poisoning and procedural complications Right Leg Bruising Secondary To Fall	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Infections and infestations Strep Throat	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
General disorders Superficial Blood Clot Left Axilla Area	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
General disorders Syncope	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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
Gastrointestinal disorders Vomiting	8.1% 6/74 • Number of events 6 • Adverse events data collected from subject enrollment up to end of study 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
Metabolism and nutrition disorders Worsening Diabetes	1.4% 1/74 • Number of events 1 • Adverse events data collected from subject enrollment up to end of study 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

Additional Information

Clinical Trials Manager

Medtronic

Phone: +972-4-9097952

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place