VirtuAl Technology to Improve the Management of Perianal Crohn's (VAMP) - PROSPECTIVE
Not applicable · Testing Virtual Examination under Anaeastehtic - 3D reconstruction imaging and Standard Care -… · 1 site · Nottingham University Hospitals NHS Trust
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Virtual Examination under Anaeastehtic - 3D reconstruction imaging (a diagnostic test) and Standard Care - Written MRI report (a diagnostic test) as a possible treatment. Condition(s) listed: Perianal Crohns Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Ability to give informed consent
- Active perianal Crohn's disease as defined by clinical assessment with fistula or abscess formation
- A clinical decision has been taken that surgery is required for perianal disease
Plus 1 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2024-07-23.
- Main results expected around 2026-07-23 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- Clinical disease activity assessment (Enrollment to 3 months post-intervention)
In the researchers’ words
Crohn's is an inflammatory condition that can affect any part of the gut. Over half a million people in the UK live with Crohn's disease and about a quarter will develop a fistula near their back passage.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Perianal Crohns Disease |
| Lead sponsor | Nottingham University Hospitals NHS Trust |
| Enrollment | 30 (estimated) |
| Start date | 2024-07-23 |
| Primary completion (est.) | 2026-07-23 |
| First posted | 2024-09-19 |
| Last updated | 2026-01-21 |
| Official title | A Feasibility Study to Assess a "Virtual" (vEUA) Technology to Improve the Management of Perianal Crohn's Disease |
| ClinicalTrials.gov ID | NCT06587646 |
Interventions
- Virtual Examination under Anaeastehtic - 3D reconstruction imaging (Diagnostic Test)
3D reconstruction of MRI imaging and review by patient and surgeon prior to surgical intervention. - Standard Care - Written MRI report (Diagnostic Test)
A standard written MRI report will be provided to the surgeon and patient prior to surgical intervention.
Full eligibility criteria (from the record)
Inclusion Criteria: * Ability to give informed consent * Active perianal Crohn's disease as defined by clinical assessment with fistula or abscess formation * A clinical decision has been taken that surgery is required for perianal disease * Ages of 18-75 Exclusion Criteria: * Inability to consent * history of Proctectomy, * absence of a diagnosis of Crohn's disease, * perianal fistulising disease not secondary to Crohn's disease, * Rectovaginal fistulas * Malignant disease * Significant cardiovascular or respiratory disease * Neurological or cognitive impairment * Significant physical disability * Significant hepatic disease or renal failure * Subjects currently (or in the last three months) participating in another research project * Pregnancy or breastfeeding * If MRI is contraindicated (e.g. pacemaker). * under 18 years old or over 75 years old
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Nottingham University Hospital NHS Trust | Nottingham | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.