RejuvenAir Lobectomy for Safety and Histology (LobectomyCAN)
2017년 5월 10일 업데이트: CSA Medical, Inc.
A Prospective Study of RejuvenAir System Radial Spray Cryotherapy to Determine Safety and Delayed Histological Effect in the Lung
RejuvenAir System treatment will be performed during preoperative bronchoscopy 2 to 90 days prior to prescheduled lung resection in Subjects requiring lobectomy for removal of peripheral tumors.
Treatment will be limited to areas of the bronchi within the lobe that will be removed, distal to the anticipated margin of resection.
Treatment should be at least 1 cm from the bronchial resection margins and away from the tumor bed.
Treated airways will be inspected via bronchoscopy at the time of thoracotomy, and examined histologically following surgical resection.
Subject participation will be from 1 to 90 days and enrollment is anticipated to take 3 months.
Subject having a RejuvenAir procedure and not going on to a resection for any reason will be followed for a maximum of 90 days for safety and undergo bronchoscopic evaluation of the treated airways at 90 days (+/- 4 Days)) post treatment.
연구 개요
상세 설명
The study is a prospective, open label, single arm, single center study.
The objective is to study the safety of the RejuvenAir System in a population of subjects who are scheduled to undergo a planned lobectomy.
A secondary objective is to determine the histological effects of RejuvenAir System treatment in the airways.
The Primary Endpoint is Safety as measured by occurrence of serious adverse events related to metered dose radial spray cryotherapy treatment performed prior to scheduled lobectomy surgery.
The patient population intended to participate in this study are subjects scheduled to undergo lobectomy for peripheral lung lesions suspicious for or known to be cancer.
Secondarily, this will enable an understanding of the histological characteristics and healing outcomes post-treatment in the airways, which will be resected.
CSA Medical has conducted bench and animal studies that support the use of the RejuvenAir System as sufficiently safe and effective to warrant advancing the product into this primary safety study in patients presenting for consideration of lobectomy.
Such patients provide a safe population to further the clinical evaluation of the system in that these subjects will receive their lobectomy or procedure 2 to 14 days following delivery of their metered liquid nitrogen treatment.
At the time of their metered liquid nitrogen treatment they will be in an operating room setting with their thoracic surgeon in attendance.
It is anticipated that subjects who agree to participate in this study will have the metered liquid nitrogen treatment at the time of evaluation of their lung lesion.
This evaluation will include bronchoscopy with ultrasound for evaluation of their lymph nodes prior to the planned surgical resection of their lung abnormality.
연구 유형
중재적
등록 (실제)
6
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Brampton, Ontario, 캐나다, L6R 3J7
- William Osler Health System
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
Males and females of 21 to 75 years of age.
- Subject is able to read, understand, and sign a written Informed Consent to participate in the study.
- Subject is scheduled within 90 days from date of study treatment for a lobectomy unrelated to this study (upper and lower lobes only). Preferred range is 2-14 days from study treatment.
- Subject has a pre-procedure post bronchodilator FEV1 of greater than or equal to 40% of predicted.
- Subject is able to undergo bronchoscopy in the opinion of the investigator or per hospital guidelines.
- Subject is able to adhere to and undergo a scheduled bronchoscope procedure prior to their clinically scheduled lobectomy surgical procedure.
Exclusion Criteria:
• Subject is pregnant, nursing, or planning to get pregnant during study duration.
- Subject is scheduled to have a pneumonectomy or has had a previous contralateral pneumonectomy.
- Subject has had prior radiation therapy which involved the lungs.
- Subject has received chemotherapy within the past 6 months, or is anticipated to be treated with chemotherapy between initial study treatment and lobectomy procedure.
- Subject has an acute pulmonary infection or pneumonia within 6 weeks prior to study bronchoscopy.
- Subject has had COPD exacerbation within 6 weeks prior to study bronchoscopy.
- Subject has bronchiectasis in the area to be treated.
- Subject has bullous emphysema. Characterized as large bullae >3 centimeters and confirmed on CT.
- Subject has had a Lung transplant.
- Subject has had lung reduction surgery, including implanted emphysema stent (s) implanted, coils or other devices for treatment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: RejuvenAir
RejuvenAir if the treatment areas are designated as Segmental, males will be dosed for 11 seconds and females for 10 seconds.
If dosing is in the Lobar area males will be dosed for 12 seconds and females for 11 seconds.
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RejuvenAir
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Safety measured by occurrence of serious adverse events related to metered dose radial spray cryothreapy
기간: prior to lobectomy-up to 14 days
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prior to lobectomy-up to 14 days
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Histology assessed by description of depth of histological treatment effect per specified treatment dose
기간: up to 90 days
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up to 90 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kashif Irshad, MDCM, MSc, WIlliam Osler Health Systems
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 8월 1일
기본 완료 (실제)
2016년 2월 1일
연구 완료 (실제)
2016년 2월 1일
연구 등록 날짜
최초 제출
2015년 6월 24일
QC 기준을 충족하는 최초 제출
2015년 6월 25일
처음 게시됨 (추정)
2015년 6월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 10일
마지막으로 확인됨
2017년 5월 1일
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. .