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

NCT07341126 | Not Yet Recruiting FDA Device

• 1 other identifier: IRAS ID 363843
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Adenoma; Bowel Cancer; Polyp Rectal; Rectal Cancer; Rectal Adenocarcinoma

Keywords

LumenEye; Rectoscopy

Outcome Measures

Primary Outcomes (1)

• Analysis of diagnostic accuracy

  LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation. To provide pilot data within the small study for the diagnostic accuracy of the LumenEye system as compared to conventional flexible endoscopy. In the first 2 stages of the study LumenEye will be compared against flexible sigmoidoscopy. Sigmoidoscopy will be considered the gold standard and will be performed directly after the LumenEye procedure. Accuracy will be calculated in standard fashion based on observations of true / false positive/ negative observations alongside measures of sensitivity and specificity.

  Baseline

Secondary Outcomes (2)

• Clinician Experience of LumenEye Examination

  Baseline

• Patient Experience of LumenEye Examination

  Baseline

Study Arms (1)

Surveillance cohort

Patients undergoing surveillance following rectal tumour removal

Diagnostic Test: LumenEye X1 digital rectoscope

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.

Surveillance cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients must have had a rectal tumour/ polyp removed within easy reach of the rigid sigmoidoscope undergoing post-operative surveillance.

You may qualify if:

• All participants who are capable of giving informed consent. All participants aged 16 years or over. All patients must have had a rectal tumour/ polyp removed within easy reach of the rigid sigmoidoscope.
• All participants must be resident in the United Kingdom.

You may not qualify if:

• Unable to give informed consent. Under the age of 16 years

Sponsors & Collaborators

• NHS Lothian: collaborator
• University of Edinburgh: lead

Study Sites (1)

Western General Hospital

Edinburgh, United Kingdom

Location

Related Publications (7)

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  PMID: 34610653 BACKGROUND

• Rullier E, Vendrely V, Asselineau J, Rouanet P, Tuech JJ, Valverde A, de Chaisemartin C, Rivoire M, Trilling B, Jafari M, Portier G, Meunier B, Sieleznieff I, Bertrand M, Marchal F, Dubois A, Pocard M, Rullier A, Smith D, Frulio N, Frison E, Denost Q. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial. Lancet Gastroenterol Hepatol. 2020 May;5(5):465-474. doi: 10.1016/S2468-1253(19)30410-8. Epub 2020 Feb 7.

  PMID: 32043980 BACKGROUND

• Bach SP, Gilbert A, Brock K, Korsgen S, Geh I, Hill J, Gill T, Hainsworth P, Tutton MG, Khan J, Robinson J, Steward M, Cunningham C, Levy B, Beveridge A, Handley K, Kaur M, Marchevsky N, Magill L, Russell A, Quirke P, West NP, Sebag-Montefiore D; TREC collaborators. Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):92-105. doi: 10.1016/S2468-1253(20)30333-2. Epub 2020 Dec 11.

  PMID: 33308452 BACKGROUND

• Brachet S, Meillat H, Chanez B, Ratone JP, Brunelle S, Tyran M, Poizat F, de Chaisemartin C, Lelong B. Case-Matched Comparison of Functional and Quality of Life Outcomes of Local Excision and Total Mesorectal Excision Following Chemoradiotherapy for Rectal Cancer. Dis Colon Rectum. 2022 Dec 1;65(12):1464-1474. doi: 10.1097/DCR.0000000000002384. Epub 2022 Jul 27.

  PMID: 35913830 BACKGROUND

• Buess G, Theiss R, Hutterer F, Pichlmaier H, Pelz C, Holfeld T, Said S, Isselhard W. [Transanal endoscopic surgery of the rectum - testing a new method in animal experiments]. Leber Magen Darm. 1983 Mar;13(2):73-7. German.

  PMID: 6621245 BACKGROUND

• Rutter MD, Brookes M, Lee TJ, Rogers P, Sharp L. Impact of the COVID-19 pandemic on UK endoscopic activity and cancer detection: a National Endoscopy Database Analysis. Gut. 2021 Mar;70(3):537-543. doi: 10.1136/gutjnl-2020-322179. Epub 2020 Jul 20.

  PMID: 32690602 BACKGROUND

• Lewis J, Askari A, Mehta A, Razak Y, Patel P, Misra R, Tilney H, Ahmed T, Ahmed M, Syeed A, Camilleri-Brennan J, Nicholls RJ, Kinross JM. A novel digital rectoscope for the triage of lower gastrointestinal symptoms in primary care: a prospective multicentre feasibility study. BJGP Open. 2022 Sep 28;6(3):BJGPO.2022.0036. doi: 10.3399/BJGPO.2022.0036. Print 2022 Sep.

  PMID: 35728817 RESULT

MeSH Terms

Conditions

Intestinal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colorectal Neoplasms; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)