A Prospective Study Comparing the Accuracy of Olympus Lucera Spectrum Technology vs Olympus Lucera Elite Technology in the in Vivo Diagnosis of Barrett's Oesophagus and Colorectal Polyps: The ELITE Study (ELITE)
Barrett's oesophagus is a condition where the lining of the oesophagus (gullet) wall changes. People with Barrett's oesophagus are at risk of developing oesophageal cancer but can have regular checkups to detect changes before they progress to cancer. Every two years patients with Barrett's are offered examination by passing a fibreoptic tube into the oesophagus (gastroscopy) to remove small tissue samples (biopsies), which are examined in the laboratory to check for changes.
Bowel cancer is the third most common cancer in the UK, and the second leading cause of cancer deaths. Prevention and early detection are the most effective strategies of dealing with bowel cancer. Most cancers develop from benign polyps (growths) in the bowel. Polyps are common and have the potential of developing into cancer over the course of many years.
Patients with a prior diagnosis of Barrett's oesophagus and colonic polyps undergo regular endoscopic examinations known as surveillance endoscopies. This is done to detect changes in the cells of Barrett's oesophagus or further polyps. Current practice is to capture recorded videos of Barrett's surveillance examinations and still images of polyps prior to their removal.
Endoscope technology continues to advance. These newly developed technologies are marketed to have claims of superiority in performance over preceding generations often without the back up of scientific data but at a significant financial cost. The aim of this study is to use endoscopic images and videos recorded as part of routine clinical practice to compare the current version of Olympus endoscopes with the new version launched by the company.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Portsmouth, 영국, PO6 3LY
- Queen Alexandra Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients attending for Barrett's surveillance OR
- Patients attending for colonic polyp surveillance or screening
- Patients are willing and able to give informed consent.
Exclusion Criteria:
- Polyp syndromes (eg FAP or Lynch Syndrome)
- Known history of IBD
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Barrett's surveillance Olympus Spectrum
Barrett's surveillance with Olympus Spectrum.
|
Current generation Olympus endoscope
|
|
실험적: Barrett's Surveillance Olympus Elite
Barrett's surveillance with Olympus ELITE.
|
New generation Olympus endoscope
|
|
실험적: Polyp Surveillance Olympus Spectrum
Colonic polyp surveillance/screening with Olympus Spectrum.
|
Current generation Olympus endoscope
|
|
실험적: Polyp Surveillancewith Olympus ELITE.
Colonic polyp surveillance/screening with Olympus ELITE.
|
New generation Olympus endoscope
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sensitivity
기간: Baseline and 1 day
|
Difference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.
|
Baseline and 1 day
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.
기간: Baseline and 1 day
|
Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.
|
Baseline and 1 day
|
|
Sensitivity of Dual Focus technology
기간: Baseline and 1 day
|
Difference in sensitivity of lesion characterisation when using dual focus technology.
|
Baseline and 1 day
|
|
Endoscopists confidence
기간: Baseline and 1 day
|
Difference in endoscopists' confidence scores in lesion characterisation between new and current technologies.
|
Baseline and 1 day
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Olympus Spectrum에 대한 임상 시험
-
University of North Carolina, Chapel HillNational Institutes of Health (NIH); Olympic Medical완전한
-
Duke UniversityNational Institute on Drug Abuse (NIDA)완전한
-
Jagiellonian UniversitySpecialist Diagnostic and Therapeutic Center MEDICINA완전한
-
Michael WallaceOlympus America, Inc.완전한
-
Shanghai Jiao Tong University School of MedicineChanghai Hospital; Peking University People's Hospital; Peking Union Medical College Hospital 그리고 다른 협력자들알려지지 않은
-
Olympus Surgical Technologies Europe빼는
-
Shanghai Jiao Tong University School of MedicineShanghai Putuo District Center Hospital; Shanghai MCC worker hospital아직 모집하지 않음조기 위암