- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02672228
Feasibility of the Vapor Nanobubble Technology for Malaria Diagnostics (MalariaSense) (MalariaSense)
Feasibility of the Vapor Nanobubble Technology (MalariSense) for Malaria Diagnostics
연구 개요
상세 설명
This is a proof of concept study that will evaluate the feasibility of a vapor nanobubble technology (MalariSense) for malaria diagnostics. The primary objective is to determine the sensitivity of MalariSense against microscopy in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia. The secondary objectives include the following;
- To determine the sensitivity of MalariSense against PCR in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia
- To determine the specificity of MalariSense in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia.
- To identify factors influencing the diagnostic accuracy of MalariSense
- To validate the protocol for a blood vessel identification for the test and assess the safety of the prototype The study site will be Basse in the Eastern region of The Gambia. The study will be conducted during the malaria transmission season (August to December 2015). Participants will be patients with suspected uncomplicated malaria presenting to the outpatient department of Basse Health centre. At baseline, suspected malaria cases (clinical assessment) will be asked to provide informed consent and then transferred to the MRC Basse field station where a finger prick blood sample will be collected for a malaria rapid diagnostic test (RDT), microscopy and on filter paper for subsequent molecular studies. In addition, they will be tested using the Malarisense Technology. Measurements will be taken from the wrist, ear lobe and finger tips. The laboratory prototype of the device will include three major components: pulsed laser with the fiber output, integrated handheld probe with the fiber launch in the center and an ultrasound sensor with pre-amplifier, and the signal acquisition hardware with software.
The study will enrol a total sample size of 50 patients with confirmed malaria. It is estimated that about 125 to 167 suspected cases will need to be screened/tested to get this sample size. The Sample size will be increased by 10% to allow for any missing values - therefore up to 185 suspected cases screened. In addition, a convenience sample of 30 malaria negative participants will be enrolled for comparisons between malaria positive and malaria negative populations. RDT positive patients will be provided with antimalarial treatment while the others will receive treatment according to their condition. Microscopy and species-specific PCR will be performed later. Microscopy results will be taken as the gold standard.
There will not be any active follow up. Study participants will be asked to come back 2 days after the test, or earlier if they notice a problem.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Basse, Upper River Region, 감비아
- Basse Health Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients presenting to the health facility with suspected uncomplicated malaria
- Provision of informed consent
Exclusion Criteria:
- Neonates and under 12 months old
- Pregnant women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: MalariaSense device
This study will involve the evaluation of a medical diagnostic device.
All participants enrolled in the study will be assessed for malaria using MalariSense Technology and will aslo get rapid diagnostic tests (RDTs), microscopy, PCR
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All participants enrolled in the study will be assessed for malaria using the intervention device called MalariaSense technology
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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"Hemozoin-generated vapour nanobubble (H-VNB) amplitude thresholds among malaria infected and uninfected individuals"
기간: Day 1
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Day 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Safety profile of Malarisense technology for malaria diagnosis
기간: Day 1 - Day 3
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Safety of the MalariSense Technology for malaria diagnosis over 3 days of observation
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Day 1 - Day 3
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Correlation of incidence rate ratio of hemozoin-positive traces with level of parasite density as determined by microscopy
기간: Day1 - Day 3
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Day1 - Day 3
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공동 작업자 및 조사자
수사관
- 수석 연구원: Umberto D'alessandro, PhD, MD, Medical Research Council Unit, The Gambia
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 (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. .
MalariaSense device에 대한 임상 시험
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Maquet Cardiopulmonary AG빼는
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Bio-Medical Research, Ltd.완전한
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Ya-Wei XuWest China Hospital; Ruijin Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai... 그리고 다른 협력자들알려지지 않은뇌졸중 | 비 판막 심방 세동