Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies
Confirmation of Clinical Effectiveness and Safety of CT-guided Percutaneous Lung Aspiration and Biopsy Performed With the Aid of the ActiSightTM Needle Guidance System
연구 개요
상세 설명
This will be a prospective, single-arm study. At least three centers in Canada will participate in the study and at least 4 different experienced staff radiologists will perform the procedures for the study.
A total of forty eight (48) consecutive subjects meeting the eligibility criteria, scheduled for clinically indicated CT guided lung biopsy or aspiration procedure at the participating centers will be invited to enroll in the study. To ensure diversity in the study population, consecutive patients will be enrolled in the following groups until these groups are fully enrolled:
Lesion size ≥1.0 cm and ≤ 1.5 cm: 10 patients; Lesion size >1.5 and ≤ 3.0 cm: 19 patients; Lesion size >3.0 cm: 19 patients.
A maximum of 24 patients will be enrolled at each center.
Informed consent will be signed prior to the procedure. Subject data collection on the day of the procedure will include demographics, relevant medical history and vital signs. Enrolled subjects will undergo CT guided percutaneous lung aspiration and/or biopsy as clinically indicated by a qualified physician, utilizing the ActiSight Needle Guidance System. Subjects will be followed-up as outlined below to assess adverse events related to the procedure. A subject's enrollment in the study will be completed after the follow-up visit or after resolution of any procedure related adverse event.
A procedure difficulty classification is defined for this study, based on existing literature. Difficulty levels for all procedures will be recorded and included in the final report.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, 캐나다, M5G1Z6
- University Health Network, Toronto General Hospital
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Quebec
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Montreal, Quebec, 캐나다, H3A1A1
- McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female subjects, 18 years of age or older at the time of enrollment;
- Subjects scheduled for clinically indicated CT guided percutaneous lung aspiration/biopsy;
- Written informed consent to participate in the study;
- Ability to comply with the requirements of the study procedures;
- Verified home address and phone number to facilitate study follow-up.
Exclusion Criteria:
- Significant coagulopathy that cannot be adequately corrected;
- Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment;
- Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study;
- Subjects who are uncooperative or cannot follow instructions;
- Mental impairment that may preclude completion of the study procedure;
- Pregnant or nursing female subjects.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Needle Guidance
Lung biopsies performed with the needle guidance system.
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Three different groups of patients defined per lesion size
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of patients with successful targeting accuracy as defined by the frequency of placing the needle at a location suitable for obtaining tissue sample from the target lesion.
기간: 30 to 60 minutes after starting the biopsy procedure
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Needle location suitable for obtaining tissue sample will be determined by a physician reviewing the CT images. All 48 subjects undergoing aspiration or biopsy procedures with the CT met the primary efficacy endpoint of placement of the procedure needle at a location suitable for obtaining a tissue sample from the target lesion as determined by the investigator (100%; 95% CI, 93-100%). |
30 to 60 minutes after starting the biopsy procedure
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure
기간: 30 to 60 minutes
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30 to 60 minutes
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Paul Narinder, MD, University Health Network, Toronto
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
폐 질환에 대한 임상 시험
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