Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202404916449600 Date of Registration: 19/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cipher
Official scientific title Oculus Cipher
Brief summary describing the background and objectives of the trial Cipher utilizes a smartphone attachment and AI-powered app for diagnosing cerebral malaria via eye examination, offering a cost-effective alternative to traditional methods. The clinical trial seeks to confirm the device's effectiveness in detecting cerebral malaria and assess its suitability in African settings. If successful, this approach could transform malaria diagnosis in resource-limited regions, enhancing accessibility and efficiency.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/07/2019
Actual trial start date 15/07/2019
Anticipated date of last follow up 15/07/2021
Actual Last follow-up date 15/07/2022
Anticipated target sample size (number of participants) 2000
Actual target sample size (number of participants) 1000
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
RSTPOC180712608 Grand Challenges Canada
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cipher Cipher was used to check their progression or degeneration every 3 days 1 - 2 weeks The intervention involves utilizing Cipher, a system comprising a smartphone attachment and AI-powered app, for diagnosing cerebral malaria through eye examination. This includes replacing expensive equipment with a low-cost, 3D printed ophthalmoscope. The clinical trial aims to validate the system's effectiveness and assess its feasibility and acceptance in African settings, potentially improving malaria diagnosis in resource-limited areas. 1000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. People with Severe Malaria or signs of severe malaria (e.g. loss of consciousness, convulsions, etc.) 2. Those residing within the community unit. 3. Those who consent to participate will be diagnosed. Those unwilling to give consent will be excluded from this study. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Month(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/07/2019 National Health Research Ethics Committee of Nigeria NHREC
Ethics Committee Address
Street address City Postal code Country
11th Floor, Federal Secretariate Complex Phase III, Ahmadu Bello Way, Abuja Abuja 900211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the clinical trial established the effectiveness of the smartphone-based diagnostic device in accurately detecting and diagnosing cerebral malaria. Additionally, the trial evaluated the feasibility and acceptability of the system, particularly in African settings. This outcome determined the potential impact of the Cipher system on improving malaria diagnosis and healthcare delivery in resource-limited regions. The outcome measures was assessed at various time points throughout the clinical trial. These include the initial baseline assessment, followed by regular intervals for monitoring and evaluation.
Secondary Outcome The evaluation of the diagnostic accuracy of the smartphone-based device compared to standard methods, assessing user satisfaction with the system, and examining its impact on healthcare delivery. These outcomes provide insights into the device's performance, usability, and potential benefits for both healthcare providers and patients. The secondary outcomes was measured at various time points throughout the clinical trial. These include baseline assessment, post-diagnosis evaluations, and follow-up visits.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ekiti State University Teaching Hospital State Hospital Road, Ado Ekiti Ado Ekiti 360101 Nigeria
Enugu State University Teaching Hospital Parklane FF6V to 6C6, Park Ln Hospital Rd, GRA, Enugu Enugu 400102 Nigeria
University of Nigerian Teaching Hospital University of Nigerian Teaching Hospital Ituku-Ozalla Enugu Port- Harcourt Express Way Enugu Enugu 400001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada MaRS Centre, West Tower 661 University Avenue, Suite 1720 Toronto, ON M5G 1M1 Toronto M5G 1M1 Canada
American Society of Mechanical Engineers Two Park Avenue New York, NY New York 10016-599 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Grand Challenges Canada MaRS Centre, West Tower 661 University Avenue, Suite 1720 Toronto, ON M5G 1M1 Toronto M5G 1M1 Canada Government Agency
COLLABORATORS
Name Street address City Postal code Country
Dr. Latunya Iyiade Adeseye Department of Ophthamology Faculty of Clinical Sciences Ekiti State University Teaching Hospital Ado Ekiti 360101 Nigeria
Dr.Olatunya Oladele Simeon Department of Paediatrics and Child Health Clinical Science, College of Medicines Ekiti State University Teaching Hospital Ado Ekiti 360101 Nigeria
Dr. Ben Edelu University of Nigerian Teaching Hospital Ituku-Ozalla Enugu Port- Harcourt Express Way Enugu Enugu 400001 Nigeria
Dr. Ndu IK Enugu State University Teaching Hospital Parklane Enugu 400102 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Ugwu emmanuel.u@microfusetech.com +2347032398492 5a Babatope Bejide Crescent, Lekki Phase 1
City Postal code Country Position/Affiliation
Lagos 105102 Nigeria CEO and Founder MicroFuse Technologies
Role Name Email Phone Street address
Public Enquiries Emmanuel Ugwu emmanuel.u@microfusetech.com +2347032398492 5a Babatope Bejide Crescent, Lekki Phase 1
City Postal code Country Position/Affiliation
Lagos 105102 Nigeria MicroFuse Technologies
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Ugwu emmanuel.u@microfusetech.com +2347032398492 5a Babatope Bejide Crescent, Lekki Phase 1
City Postal code Country Position/Affiliation
Lagos 105102 Nigeria Research and Development at MicroFuse Technologies
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data (IPD) Sharing Statement for this trial emphasizes transparency and collaboration by providing access to anonymized participant data upon request. Researchers can request access by contacting the principal investigator, and approved requests will be subject to a data access agreement ensuring responsible use and confidentiality protection. IPD will be anonymized and shared in compliance with data protection regulations, with restrictions applied when necessary to safeguard participant privacy and ongoing research interests. Through IPD sharing, the trial aims to foster scientific collaboration and advance medical knowledge. Clinical Study Report,Informed Consent Form,Study Protocol 1 year Our data is open. Data request would be processed and granted by Emmanuel Ugwu.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://microfusetech.com Yes 09/04/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/04/2024 Result - 09/04/2024 Result - 09/04/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/file/d/1g3zdN6t9gZ--rahPBpeLPuEAjOjWKK37/view?usp=sharing
Changes to trial information