Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis
調査の概要
詳細な説明
Ulcerative colitis (UC) is a disorder of unknown origin that may be characterized by acute and chronic inflammation of the colon. The extent of the colonic mucosal inflammation varies among individuals, but the disease almost always involves the rectum. Ulcerative colitis has required evaluation by colonoscopy to determine the extent and severity of the disease. The PillCam platform 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 PillCam platform 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 PillCam platform may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon.
The PillCam® SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for small bowel evaluation has been ingested to date by more than 700,000 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. Further details of the PillCam® Colon Capsule Endoscope (PCCE) can be found in the device description section.
In previous studies, the PillCam colon platform has been shown to be safe and to be able to demonstrate colon polyps and cancers. This study is an extension to a trial evaluating the use of PCCE in ulcerative colitis that has already been completed in Hong Kong (n=40). This study is designed to assess the ability of the capsule to accurately detect inflammatory lesions and thus classifying the extent and severity of disease in subjects with ulcerative colitis in comparison to traditional colonoscopy.
研究の種類
入学 (実際)
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease
The study population will consist of subjects who fulfill all the inclusion criteria and none of the exclusion criteria.
説明
Inclusion Criteria:
- Subjects 18-70
- Suspected or known ulcerative colitis patients
Exclusion Criteria:
- Subject has dysphagia
- Subject has congestive heart failure
- Subject who can not tolerate bowel preparation
- Poor bowel preparation
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
- Subject has a cardiac pacemaker or other implanted electro-medical devices.
- Subject is pregnant
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- 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 any condition, which precludes compliance with study and/or device instructions.
- Subject suffers from life threatening conditions
- Subject is currently participating in another clinical study
- Subject has constipation (less than 3 bowel movements/week)
- Subject has known slow gastric emptying time
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
---|
A
Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Agreement level between capsule and colonoscopy in classifying colitis into the above (see section 3.1) categories.
時間枠:within 7 days
|
within 7 days
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Number, type and severity of adverse events with both PCCE and standard colonoscopy
時間枠:Within 7 days
|
Within 7 days
|
Accuracy parameters for detecting active UC
時間枠:within 7 days
|
within 7 days
|
Disease severity scoring index for both PCCE and .standard colonoscopy
時間枠:within 7 days
|
within 7 days
|
Colon cleansing level score for both PCCE and standard colonoscopy.
時間枠:within 7 days
|
within 7 days
|
Grading of the bubbles interference at the colon for PCCE.
時間枠:Within 7 days
|
Within 7 days
|
Percentage of excreted colon capsules
時間枠:Within 7 Days
|
Within 7 Days
|
PCCE transit time from ingestion to excretion and colon transit time
時間枠:Within 7 Days
|
Within 7 Days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Josef Sung, Prof.、Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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