G-EYE™ Colonoscopy Clinical Efficacy
Research type
Research Study
Full title
Prospective randomized trial to compare the clinical efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy with Standard HD Colonoscopy
IRAS ID
137003
Contact name
Sauid Ishaq
Contact email
Clinicaltrials.gov Identifier
Research summary
Colorectal cancer (CRC) is the second leading cause of cancer in the US and Europe. While being fatal in its advanced stages, exhibiting a five-year survival rate of less than 10%, it is by far the most preventable cancer by early detection. Over 90% of the CRC incidents develop over years from polyps that grow in the colon. Timely detection and removal of these polyps prevent the disease. \nColonoscopy is the gold-standard method for CRC screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. However, it is well known that lesions are missed during routine colonoscopy. This is mostly due to polyps hidden behind the folds, shallow polyps and polyps that are masked by the colon’s topography.\nWhen withdrawing the Colonoscope during the examination of the colon, the G-EYE™ balloon is inflated, thus straightening intestinal folds, smoothening colon topography and improving colon visibility.\nThe purpose of the study is to compare the adenoma (pre-cancerous polyps) detection rate obtained by performing G-EYE™ Colonoscopy compared to the detection rate obtained by Standard Colonoscopy.\nThe study will include subjects over the age of 50, referred to colonoscopy for screening, following positive FOBT (fecal occult blood test) testing (detects blood in faeces), change of bowel habits or for surveillance colonoscopy (history of adenoma resection).\nThis is a multicenter European study enrolling 1000 subjects.\nSubjects will be randomized into 1 of 2 groups:\nGroup A: Subjects will undergo a G-EYE™ colonoscopy.\nGroup B: Subjects will undergo a standard colonoscopy\nAll detected polyps are removed and sent for histological evaluation. \nReferences are provided as part of the study protocol
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/0051
Date of REC Opinion
26 Mar 2014
REC opinion
Further Information Favourable Opinion