A feasibility study to assess a point-of-care endo-luminal diagnostic tool and tele-endoscopy platform in reducing time to histological confirmation of rectal cancer & providing remote diagnostic support from an international faculty (Sitara study)

Prospective, phase 1 feasibility study

To determine patient and clinician acceptability and diagnostic utility of a novel point of care digital rectoscopy device and its associated software platform in reducing time to histological confirmation of rectal cancer

• Time to histological diagnosis for rectal cancer
• Clinician acceptability
• Patient acceptability
• Patient safety
• Diagnostic accuracy
• Diagnostic sensitivity and specificity for an ‘abnormal rectum’
• Economic analysis of LumenEye

Adult patients presenting to secondary care services because of a change in bowel habit, rectal bleeding or assessment for symptoms suspicious of rectal cancer

Patients aged 18-74

Patients presenting to secondary care settings

With any of:

1. Rectal bleeding
2. Established rectal cancer
3. Positive Faecal occult blood test / Faecal immunochemical test (FIT) or
4. Faecal calprotectin
5. Any symptom that would warrant referral on a cancer referral

6 Months

SurgEase

Tata Memorial Hospital, Mumbai
Imperial College
Kings Hospital