Digestive System DiseaseREVENDONCT06414239
Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask
A study testing Use of a VR mask in people with Digestive System Disease, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Digestive System Disease
- What is being tested?
- Use of a VR mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia
Who cannot join
- 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
Show all 10Show fewer
- Emergency examination
- Patient participating in another interventional research on digestive endoscopy
- Patient not speaking French
- Patient under guardianship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle
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 of the examination. Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA. A 2017 meta-analysis showed that the use of virtual reality (VR) reduced pain and anxiety during care for burn victims, in trauma and oncology. In upper digestive endoscopy, retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia. Thus, if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability, more examinations without GA could be considered. It could also have an economic impact.
- Conditions
- Digestive System Disease
- Being tested
- Use of a VR mask, Standard of care
- Keywords
- Lower digestive endoscopy whatever the indication, Digestive endoscopy, Colonoscopy, Virtual reality
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a VR maskDevice
Virtual reality mask
Standard of careOther
Without any premedication or anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Coloscopy with a virtual reality mask Receives: Device: Use of a VR mask |
| Control group | Other | Coloscopy without any premedication or anesthesia Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At day 0
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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
Measured: At 1 month
Patient's opinion to repeat the examination under the same conditions
It will be assesses by the Likert scale
Measured: At day 0
Patient's opinion to repeat the examination under the same conditions
It will be assesses by the Likert scale
Measured: At 1 month
Duration of the examination
Time between introduction and removal of the colonoscope
Measured: At day 0
Total duration of the procedure
time between entering and leaving the room
Measured: 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.
Measured: At day 0
Proportion of procedures where the VR mask is removed at the patient's request
Measured: Up to 30 months
Proportion of colonoscopies with detection of at least one adenoma
Measured: Up to 30 months
Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group
Measured: Up to 30 months
Operator satisfaction
Assessed by the Analogue Visual Scale examination
Measured: Up to 30 months
Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414239
- Sponsor's protocol ID
- APHP220675
- Acronym
- REVENDO
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle
- ClinicalTrials.gov ID
- NCT06414239
- Acronym / sponsor ID
- REVENDO / APHP220675
- Conditions
- Digestive System Disease
- Keywords
- Lower digestive endoscopy whatever the indication, Digestive endoscopy, Colonoscopy, Virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of the examination. Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA. A 2017 meta-analysis showed that the use of virtual reality (VR) reduced pain and anxiety during care for burn victims, in trauma and oncology. In upper digestive endoscopy, retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia. Thus, if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability, more examinations without GA could be considered. It could also have an economic impact.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: Use of a VR maskColoscopy with a virtual reality mask |
| Control group | Other | Other: Standard of careColoscopy without any premedication or anesthesia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of a VR maskVirtual reality mask | Device | Interventional group |
| Standard of careWithout any premedication or anesthesia | Other | Control group |
Primary outcome
Rate of cecal intubation
Time frame: At day 0
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
14 secondary outcomes
Maximum pain assessed by the patient by numerical scale
Time frame: At day 0
Maximum pain assessed by the patient by numerical scale
Time frame: At 1 month
Maximum anxiety assessed by the patient by numerical scale
Time frame: At day 0
Maximum anxiety assessed by the patient by numerical scale
Time frame: At 1 month
Patient's opinion to repeat the examination under the same conditions
Time frame: At day 0
Patient's opinion to repeat the examination under the same conditions
Time frame: At 1 month
Duration of the examination
Time frame: At day 0
Total duration of the procedure
Time frame: At day 0
Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum
Time frame: At day 0
Proportion of procedures where the VR mask is removed at the patient's request
Time frame: Up to 30 months
Proportion of colonoscopies with detection of at least one adenoma
Time frame: Up to 30 months
Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group
Time frame: Up to 30 months
Operator satisfaction
Time frame: Up to 30 months
Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success
Time frame: Up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a VR mask in people with Digestive System Disease, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact My-Linh TRAN-MINH, Dr (+33142499597, mylinh.tranminh@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cecal intubation (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.