Assessment of Cytosponge II collection system
Research type
Research Study
Full title
Assessment of a minimally invasive oesophageal cytology collection system (CE marked) in patients with Barrett’s oesophagus (specimen adequacy, biomarker sensitivity for BO, and safety)
IRAS ID
143609
Contact name
Rebecca C. Fitzgerald
Contact email
Sponsor organisation
Covidien - BARRX Division
Research summary
Barrett’s oesophagus (BO) is a recognized precursor lesion for oesophageal adenocarcinoma (OAC). The risk for OAC is higher depending on the severity of baseline dysplasia grade. Current surveillance strategies are not optimal for this disease state, as they are hindered by cost issues, inter-observer variability in histology interpretation, biopsy sampling error (under and over staging), and the fact that surveillance alone does not prevent disease progression.
The treatments for intraepithelial neoplasia in BO have recently undergone a paradigm shift with the rapid development of outpatient endoscopic technologies, such as mucosal resection and radiofrequency ablation. The ideal method for diagnosing BO is white light upper endoscopy and biopsy, despite limitations such as the invasiveness of the procedure, the need for great expertise, the high cost, and the subjective nature of the diagnosis.
There exists a need for a safe, minimally invasive, inexpensive, and easily administered method aimed at the primary care setting to diagnose BO. We have shown that non-endoscopic screening is feasible and safe using a new device called the capsule sponge, or cytosponge I, which was developed in our laboratory. This device has received a letter of non-objection from the MHRA.
Presently, a refined version of our cytosponge I (hereafter, cytosponge II) is available from Covidien GI Solutions. Cytosponge II was developed from the cytosponge I specification and design, with the additional priority of a more reproducible manufacture, standardization of dimensions, and other quality related. Cytosponge II is pending FDA 510k clearance and CE marking will be available before the study starts.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/0015
Date of REC Opinion
12 Feb 2014
REC opinion
Further Information Favourable Opinion