Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease (MA-51)
This study has been completed.
Sponsor:
Given Imaging Ltd.
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00487396
First received: June 14, 2007
Last updated: April 17, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: March 20, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Single Blind (Investigator); Primary Purpose: Diagnostic |
| Condition: |
Crohn's Disease |
| Intervention: |
Device: Capsule Endoscopy |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Study started on September 2007 and data collection completed on October 2010. Study conducted in 10 clinical sites (hospitals and private clinics) in the USA, Sweden, Canada and Israel |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
|
98 patients enrolled in this study. 18 cases excluded due to the following: 15 cases were excluded due to noncompliance with the protocol. 1 patient withdrew consent before any study procedure. 1 patient could not ingest the capsule. 1 patient refused to undergo the ileocolonoscopy and SBFT. Therefore 80 patients were included in the analysis |
Reporting Groups
| Description | |
|---|---|
| SB Capsule Then Standard Ileocolonoscopy | Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison. |
Participant Flow: Overall Study
| SB Capsule Then Standard Ileocolonoscopy | |
|---|---|
| STARTED | 98 |
| COMPLETED | 95 |
| NOT COMPLETED | 3 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| SB Capsule Then Standard Ileocolonoscopy | Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison. |
Baseline Measures
| SB Capsule Then Standard Ileocolonoscopy | |
|---|---|
|
Number of Participants
[units: participants] |
80 |
|
Age
[units: participants] |
|
| <=18 years | 20 |
| Between 18 and 65 years | 60 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
28.35 ± 13.25 |
|
Gender
[units: participants] |
|
| Female | 38 |
| Male | 42 |
|
Region of Enrollment
[units: participants] |
|
| United States | 46 |
| Canada | 0 |
| Israel | 20 |
| Sweden | 14 |
Outcome Measures
| 1. Primary: | The Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related [ Time Frame: four months from enrollment ] |
| 2. Secondary: | Small Bowel Disease Present (Will be Categorized as Mild, Moderate or Severe)or Suspicious for Small Bowel Disease or No Small Bowel Disease Present. [ Time Frame: four months from enrollment ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 3. Secondary: | The Additional Diagnostic Value and Sensitivity of CE Compared With Ileo-colonoscopy and SBFT Will be Evaluated by the Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related. [ Time Frame: four months from enrollment ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
Serious Adverse Events Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 2.5% |
|---|
Reporting Groups
| Description | |
|---|---|
| Adverse Events Related to Ileocolonoscopy | AE related to the ileocolonoscopy procedure |
| Adverse Events Related to Capsule | AE related to the capsule endoscopy procedure |
Other Adverse Events
| Adverse Events Related to Ileocolonoscopy | Adverse Events Related to Capsule | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected / at risk | 1/80 | 2/80 |
| General disorders | ||
| Weakness, skin irritation, delayed capsule excretion † | ||
| # participants affected / at risk | 1/80 (1.25%) | 2/80 (2.50%) |
| # events | 80 | 80 |
| † | Events were collected by systematic assessment |
|---|
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Director, Clinical Affairs
Organization: Given Imaging
phone: +972-4-9097777
e-mail: Hila.Debby@givenimaging.com
Organization: Given Imaging
phone: +972-4-9097777
e-mail: Hila.Debby@givenimaging.com
No publications provided
| Responsible Party: | Given Imaging Ltd. |
| ClinicalTrials.gov Identifier: | NCT00487396 History of Changes |
| Other Study ID Numbers: | MA-51 |
| Study First Received: | June 14, 2007 |
| Results First Received: | March 20, 2012 |
| Last Updated: | April 17, 2012 |
| Health Authority: | United States: Institutional Review Board |