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Assistance Publique - Hôpitaux de ParisImprovement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask (REVENDO) 240 Virtual
Clinical Trial NCT06414239 (REVENDO) is an interventional study for Digestive System Disease and is currently not yet recruiting. Enrollment is planned to begin on 1 June 2024 and continue until the study accrues 240 participants. Led by Assistance Publique - Hôpitaux de Paris, this study is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 16 May 2024.
Brief Summary
90% of colonoscopies are performed with general anesthesia (GA). GA carries risks and requires a prior anesthesia consultation, a dedicated team and technical platform on the day of the examination. These constraints increase the time it takes to organize examinations. This was particularly highlighted during the recent health crisis. The success of colonoscopy without GA varies depending on the patient's experience ...Show More
Official Title
Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle
Conditions
Digestive System DiseaseOther Study IDs
- REVENDO
- APHP220675
NCT ID Number
Start Date (Actual)
2024-06
Last Update Posted
2024-05-16
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
240
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Lower digestive endoscopy whatever the indication
Digestive endoscopy
Colonoscopy
Virtual reality
Digestive endoscopy
Colonoscopy
Virtual reality
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalInterventional group Coloscopy with a virtual reality mask | Use of a VR mask Virtual reality mask |
OtherControl group Coloscopy without any premedication or anesthesia | Standard of care Without any premedication or anesthesia |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Rate of cecal intubation | Success of a total colonoscopy defined by the rate of cecal intubation (visualization of the ileocecal valve and the appendicular orifice with the endoscope located near the appendicular orifice) or visualization of the ileocecal anastomosis in case of history of surgery removing the ileocaecal valve | At day 0 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Maximum pain assessed by the patient by numerical scale | The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain | At day 0 |
Maximum pain assessed by the patient by numerical scale | The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain | At 1 month |
Maximum anxiety assessed by the patient by numerical scale | The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety | At day 0 |
Maximum anxiety assessed by the patient by numerical scale | The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety | At 1 month |
Patient's opinion to repeat the examination under the same conditions | It will be assesses by the Likert scale | At day 0 |
Patient's opinion to repeat the examination under the same conditions | It will be assesses by the Likert scale | At 1 month |
Duration of the examination | Time between introduction and removal of the colonoscope | At day 0 |
Total duration of the procedure | time between entering and leaving the room | At day 0 |
Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum | Between the introduction of the colonoscope and 30 minutes maximum. It can be the ileum in the event of a history of surgery removing the valve. | At day 0 |
Proportion of procedures where the VR mask is removed at the patient's request | Up to 30 months | |
Proportion of colonoscopies with detection of at least one adenoma | Up to 30 months | |
Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group | Up to 30 months | |
Operator satisfaction | Assessed by the Analogue Visual Scale examination | Up to 30 months |
Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success | Up to 30 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia
- Hearing problems or low vision
- Psychiatric or cognitive disorders hindering communication
- History of epilepsy
- Claustrophobia which can lead to a rejection of the virtual reality mask
- History of cybercynetosis during previous use of VR
- Chronic abdominal pain with baseline Visual analogue scale (VAS) > 5
- Emergency examination
- Patient participating in another interventional research on digestive endoscopy
- Patient not speaking French
- Patient under guardianship
Assistance Publique - Hôpitaux de Paris967 active studies to exploreStudy Central Contact
Contact: My-Linh TRAN-MINH, Dr, +33142499597, [email protected]
Contact: Jérôme Lambert, Pr, +33142499742, [email protected]
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