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Authors
Budge, James
Carrell, Tom
Yaqub, Medeah
Wafa, Hatem
Waltham, Matt
Pilecka, Izabela
Kelly, Joanna
Murphy, Caroline
Palmer, Stephen
Wang, Yanzhong
Clough, Rachel E
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Funding
Funding for this research was provided by:
Invention for Innovation Programme (NIHR201004)
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Article History
Received: 31 July 2023
Accepted: 6 October 2023
First Online: 25 March 2024
Declarations
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: Individual participants will consent to participate. The trial will be conducted in compliance with the principles of the Declaration of Helsinki (1996) and the principles of GCP and in accordance with all applicable regulatory requirements including but not limited to the Research Governance Framework and the Medicines for Human Use (Clinical Trial) Regulations 2004, as amended in 2006 and any subsequent amendments.This protocol and related documents have been submitted for review to Health Research Authority (HRA) and Research Ethics Committee (REC). MHRA approval is not required as Cydar-EV is CE Marked as a medical device and is being used as intended. The chief investigator will submit an end of study report at the conclusion of the trial to the REC.
: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.
: Tom Carrell is a Cydar Medical company employee.
