An internal pilot study of a novel rectal mucocellular sampling device to allow next-generation sequencing for colorectal disease.

"Declarations Conflict of interestFinancial Interests ORI-EGI-02 Study Group: Author HN Humphrey is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. Author A Diodato is employed by Origin Sciences. Author J-C Isner is employed by Origin Sciences. Author E Walker is employed by Origin Sciences. Author J Lacey-Coulson holds Origin Sciences share options. Author IR Daniels holds Origin Sciences share options and is a paid consultant to Origin Sciences. Author B Nedjai holds Origin Sciences share options and is a paid consultant to Origin Sciences. ET Walker is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. H Sisodia is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. H Rottenberg is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. S Bird is a research nurse funded by an unrestricted research grant from Origin Sciences. GAR Jones is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. D Wise is employed by Origin Sciences. SJ Spencer holds Origin Sciences share options and is contracted to Origin Sciences as Clinical Study Manager.FD McDermott has no financial disclosures relevant to this study. NJ Battersby has no financial disclosures relevant to this study. C Cunningham has no financial disclosures relevant to this study. Ethical approval for research involving human participantsAll procedures performed the ORI-EGI-02 study involving human participants were in accordance with the ethical standards of the national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Health Research Authority/National Research Ethics Service/ East Midlands-Nottingham 1 Research Ethics Committee (REC Reference: 19/EM/0266). The study was completed in accordance with STROBE guidelines. Ethics ApplicationHealth Research Authority/National Research Ethics Service/East Midlands-Nottingham 1 Research Ethics Committee. REC reference: 19/EM/0266; Protocol number: Ori-EGI-02; IRAS project ID: 263745; ClinicalTrials.gov: NCT04659590. Consent to participateWritten informed consent was obtained from all individual participants included in the study. Consent to publishWritten informed consent obtained from all individual participants included a signed statement regarding permission to publish. Conflict of interest Financial Interests ORI-EGI-02 Study Group: Author HN Humphrey is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. Author A Diodato is employed by Origin Sciences. Author J-C Isner is employed by Origin Sciences. Author E Walker is employed by Origin Sciences. Author J Lacey-Coulson holds Origin Sciences share options. Author IR Daniels holds Origin Sciences share options and is a paid consultant to Origin Sciences. Author B Nedjai holds Origin Sciences share options and is a paid consultant to Origin Sciences. ET Walker is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. H Sisodia is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. H Rottenberg is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. S Bird is a research nurse funded by an unrestricted research grant from Origin Sciences. GAR Jones is a surgical research fellow funded by an unrestricted research grant from Origin Sciences. D Wise is employed by Origin Sciences. SJ Spencer holds Origin Sciences share options and is contracted to Origin Sciences as Clinical Study Manager. FD McDermott has no financial disclosures relevant to this study. NJ Battersby has no financial disclosures relevant to this study. C Cunningham has no financial disclosures relevant to this study."

"Funding The ORI-EGI-02 study was funded by Origin Sciences Ltd."

"The study was conducted in January 2020—May 2021 at four sites in the UK: The Shrewsbury & Telford NHS Trust, The Royal Devon & Exeter NHS Foundation Trust, The Royal Cornwall NHS Foundation Trust, and Oxford Hospitals NHS Foundation Trust. The study is registered at clinicaltrials.gov (NCT04659590) as ORI-EGI-02."