Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Sponsor number: AC25074 | Other Identifier | University of Edinburgh | |
| IRAS Study ID: 349888 | Other Identifier | IRAS | |
| R&D Number: 2025/0152 | Other Identifier | NHS Lothian |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
In this study the investigators will recruit patients who have already had an upper gastrointestinal (GI) tract endoscopy (OGD) and lower GI tract investigations which did not identify the source of iron deficiency anaemia, and who need the small bowel to be investigated. This will comprise both patients who would have proceeded directly to small bowel capsule endoscopy (SBCE) under standard care and also those from whom an initial 'watch and wait' approach may have been adopted before proceeding to SBCE. The investigators propose to investigate these patients during a single patient visit to Leith Community Treatment Centre, Edinburgh, Scotland, with a CE marked robotic capsule system which can examine both the upper GI tract (i.e. the oesophagus and the stomach) and the small bowel in one investigation using a magnetic guided capsule.
The aim of the study is to compare the findings from OGD with the robotic capsule system and to determine if such a system may safely replace OGD - thus examining the upper GI tract and small bowel for IDA in one less invasive investigation. This has the potential to decrease patient discomfort, stress and anxiety, while also reducing pressure on busy endoscopy departments, helping to ensure that the right patients receive the right investigations in a timely manner.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted magnetically controlled capsule endoscopy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot assisted magnetically controlled capsule endoscopy | Diagnostic Test | Examination of the upper GI tract (oesophagus and stomach) with robot assisted magnetically controlled capsule endoscopy. Examination of the small bowel will be completed using the same capsule, however it will not be robot assisted. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of robot assisted magnetically controlled capsule endoscopy compared to upper GI endoscopy (OGD) | The principal research objective that this study seeks to address is if robot assisted magnetically controlled capsule endoscopy may be safely and effectively used as an alternative to upper GI endoscopy (OGD) (i.e. it is non-inferior when compared to OGD) in the investigation of patients with iron deficiency anaemia. This will be achieved through a review of OGD reports, the findings of which will be recorded. These will be directly compared to the findings at robot assisted magnetically controlled capsule endoscopy and any differences noted. Cohen's kappa coefficient will be used to assess the degree of diagnostic agreement between OGD and robot assisted magnetically controlled capsule endoscopy, with reference to the total number of lesions and specific pathology detected. | From individual patient enrolment to completion and reporting of capsule endoscopy examination |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John N Plevris, MD, DM, PhD(E), FRCPE, FEBGH | Contact | 0131 242 1631 | j.plevris@ed.ac.uk | |
| Rebecca K Grant, MBChB BSc(Hons) MA(Hons) MSc | Contact | rebecca.grant9@nhs.scot |
| Name | Affiliation | Role |
|---|---|---|
| John N Plevris, MD, DM, PhD(E), FRCPE, FEBGH | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leith Community Treatment Centre | Recruiting | Edinburgh | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34555347 | Background | Xiao YF, Wu ZX, He S, Zhou YY, Zhao YB, He JL, Peng X, Yang ZX, Lv QJ, Yang H, Bai JY, Fan CQ, Tang B, Hu CJ, Jie MM, Liu E, Lin H, Koulaouzidis A, Zhao XY, Yang SM, Xie X. Fully automated magnetically controlled capsule endoscopy for examination of the stomach and small bowel: a prospective, feasibility, two-centre study. Lancet Gastroenterol Hepatol. 2021 Nov;6(11):914-921. doi: 10.1016/S2468-1253(21)00274-0. Epub 2021 Sep 21. |
Not provided
Not provided
Data will not be shared at an individual patient level
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013514 | Surgical Procedures, Operative |