Use of a Novel Camera to Check the Bowel After Polyp or Tumour Removal

Sponsor
University of Edinburgh
Study ID
NCT07341126
Status
Not Yet Recruiting

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Conditions

  • Bowel Cancer
  • Polyp Rectal
  • Rectal Adenocarcinoma
  • Rectal Adenoma
  • Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LumenEye X1 digital rectoscope — DIAGNOSTIC_TEST
    The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.

Study Details

1.1 Polyps or tumours in the lower part of the bowel (rectum) can be removed using instruments inserted through the bottom which avoids major surgery and the possibility of a stoma bag (colostomy). Afterwards, it is important to check the area with regular camera tests. If checks are delayed, re-growths could be serious and may be untreatable. COVID and other factors have led to long waiting lists for camera checks and in NHS Lothian around 20% of all camera checks are done more than 6 months late. The investigators want to try a new camera and approach that would allow us to reduce waiting lists. Using a short camera called a 'rectoscope' to check the lower bowel has already been shown to be safe, comfortable and acceptable to patients with other conditions. In fact, patients are unlikely to feel or realise any difference between the rectoscope and standard camera tests. The investigators want to show that this 'rectoscope' can be safely used in the outpatient clinic with an enema (suppository) instead of strong bowel medicine taken by mouth the day before. This would mean the camera checks happen on time and would reduce waiting lists for other important tests. The investigators will include 30 patients across three stages of our study. In the first set of patients, the investigators will use the rectoscope alongside the usual endoscope in the endoscopy room using the usual oral bowel medicine. This stage will check the rectoscope is acceptable to the patient and the doctor. In the next 10 patients the investigators will use a suppository instead of oral bowel medicine still using both cameras. Finally, the investigators will use the rectoscope in the outpatient clinic with an suppository to show this is an easy, effective and acceptable way to deliver timely camera checks.

Key Dates

First listed
Jan 14, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Surveillance cohort
    Patients undergoing surveillance following rectal tumour removal

Primary Outcome Measure

Analysis of diagnostic accuracy [ Time Frame: Baseline ]

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