Collecting Recorded Videos of Colonoscopy Screening Tests
Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
연구 개요
상태
정황
상세 설명
Primary objectives • To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.
Secondary objectives
• When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Hadera, 이스라엘, 3810101
- Hillel Yaffe Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Subjects shall be recruited by the investigator from within the investigator's patient population of colonoscopy. In this study one site will participate and enroll up to 300 subjects according to the inclusion/exclusion criteria. Each subject (up to 300 subjects) included will pass one regular colonoscopy screening test which will be recorded in the way which is described above.
Enrolled subjects that did not complete the full course of the study will be replaced.
설명
Inclusion Criteria:
Subjects must meet all the criteria related to regular colonoscopy according to the standard of care at the Gastroenterolgy Department of the selected center. In addation, the following criteria have to be met to be eligible for the study:
- Able to read, understand and provide written Informed Consent;
- Females or males - older than 18 years old
Exclusion Criteria:
Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:
- Bleeding disorder or unacceptable risk of bleeding
- Terminal illness or life threatening malignancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality.
기간: Half an hour from the end of the procedure at which the video was recorded.
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Each recorded video is visually inspected immediately at the end of the procedure by an experienced team member who rates it with a number between 1 (low quality) to 10 (high quality).
Only videos with rate above 7 are considered as having sufficient high quality.
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Half an hour from the end of the procedure at which the video was recorded.
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De-Identified procedure report which was visually inspected to verify that it includes all the needed details about the polyps that were detected during the procedure.
기간: Half an hour from the end of the procedure for which the procedure report was filled-in.
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Each de-Identified procedure report is visually inspected immediately at the end of the procedure by an experienced team member who gives it binary score (0 or 1), 1 if it includes all the needed details about the polyps that were detected during the procedure, and 0 if it does not include all the needed details about the polyps that were detected during the procedure.
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Half an hour from the end of the procedure for which the procedure report was filled-in.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Yael Kopelman, MD, Hillel Yaffe Medical Center
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0009-16-HYMC
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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