ColonoscopyCOLDiSNCT04465383
Digital Sedation: Virtual Reality Hypnosis During Colonoscopy
A study testing Aqua© 30 on Oncomfort SedakitTM and Propofol in people with Colonoscopy, run by Oncomfort at 1 site in Belgium.
Trial summary
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Aqua© 30 on Oncomfort SedakitTM and Propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jun 2020to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)
- Provision of written informed consent
Who cannot join
- Scheduled dilation
- Active Crohn Disease
- Low auditory acuity that precludes use of the device
- Low visual acuity that precludes use of the device
- Head or face wounds precluding use of the device
- Schizophrenia
Show all 9Show fewer
- Dizziness
- Water/sea phobia
- Non-proficiency in French or Dutch (research language)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Monocentric Study Comparing Digital Sedation Versus Intravenous Sedation Among Patients Undergoing Colonoscopy
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.
Read the detailed description
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.
Participants will be recruited during the anesthesiology consultation conducted in preparation for colonoscopy. Those with indication for screening or diagnostic colonoscopy under conventional intravenous sedation (propofol) and willing to participate will provide their written informed consent and will be randomized (2:1) between two arms:
- Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if needed upon patient request
- Control arm: conventional intravenous sedation (propofol)
The study will be divided into three stages, with randomization (2:1) maintained throughout. In the first stage, accrual will be halted when about 45 patients have been randomized, at least 27 of whom being evaluable patients randomized to the experimental arm. A non-binding futility analysis is planned for the primary outcome. In the second stage, accrual will be halted when about 90 patients have been randomized. A non-binding futility analysis is planned for the primary outcome. If the milestones are met, accrual will be reopened to the second stage and the study will continue to the planned final accrual of 177 patients (118 to experimental and 59 to control arm, respectively). At the end of the recruitment of Stage 1 and 2, an analysis of the secondary outcomes will also be run. Results of these analysis could also impact the decision for pursuing to second/ third stage.
- Conditions
- Colonoscopy
- Being tested
- Aqua© 30 on Oncomfort SedakitTM, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqua© 30 on Oncomfort SedakitTMDevice
Digital Sedation session consists in a virtual reality software (Aqua© 30 Version 3.0, Oncomfort SA, Waver, Belgium) including a clinical hypnosis script.Patients in the intervention group will undergo a 30-minute Digital Sedation program through a VR headset and headphones. This medical device called Oncomfort SedakitTM has been created to reduce anxiety and pain during medical/ surgical interventions
PropofolDrug
Standard sedation starting doses of 1 µg/ml to 6 µg/ml depending on patient's reaction and titrated incrementally by 0.5µg/ml. Doses are adapted according to the level of comfort and needs of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Digital Sedation | Experimental | Digital Sedation with rescue intravenous sedation (propofol) if needed upon patient request Receives: Device: Aqua© 30 on Oncomfort SedakitTM; Drug: Propofol |
| Intravenous sedation | Active comparator | Control arm with conventional Intravenous sedation Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the feasibility of using digital sedation in colonoscopy (stage 1)
cecal intubation rate, rate of rescue sedation
Measured: Day 1
To demonstrate adequate performance of colonoscopy using digital sedation (stage 2)
cecal intubation rate, rate of rescue sedation
Measured: Day 1
Secondary outcomes (9)
To compare patient experience in both arms
Measure of satisfaction by Likert scale (0 to 5), pain by Visual Analogue Scale (VAS 0 to 10), anxiety by Visual Analogue Scale (VAS 0 to 10), comfort by Visual Analogue Scale (VAS 0 to 10), Preferred type of sedation, Recall of the procedure, Experienced side effects/ AE
Measured: Day 1 & Day 2 Follow-up call
To compare measures of colonoscopy performance in both arms
Compare Cecal intubation rates, Adenoma detection rates, Withdrawal time,Total duration of colonoscopy, Total duration of sedation,Total length of stay in procedure room,Total length of stay in recovery room,Total length of stay in hospital
Measured: Day 1
To assess the need for rescue sedation in the experimental arm
Proportion of patients with cecal intubation without rescue sedation in the experimental arm, Frequency of use of intravenous sedation (propofol) and of complete interruption of digital sedation
Measured: Day 1
To compare use of sedation medication in both arms
Average (per patient) total doses of sedation medication per arm
Measured: Day 1
To assess gastroenterologist and anesthesiologist satisfaction in both arms
Measure of satisfaction by Likert scale (0 to 5) and of perceived facilitation or impediment of the procedure by Digital Sedation as measured by Likert scale (0 to 5)
Measured: Day 1
To assess gastroenterologist and anesthesiologist stress in both arms
Measure of stress by Visual Analogue Scale (VAS 0 to 10)
Measured: Day 1
To compare physiologic measures in both arms
Oxygen saturation (minimal observed during procedure), MBP (min/max.), Heart rate (min/max)
Measured: Day 1
To assess difficulty or ease of the procedure in both arms
Number of abdominal manipulations and patient mobilizations
Measured: Day 1
To compare the safety in both arms
Frequency and type of AEs and SAEs, Frequency and severity of episodes of desaturation and of HR/ MBP changes
Measured: Screening, Day 1 & Day 2 Follow-up call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start25 Jun 2020
- Primary completion20 Sep 2021
- Study completion21 Dec 2021
Why it stopped: Recruitment too complicated during pandemics. Phase 2 of recruitment completed and enough data available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncomfort
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Erasme University Hospital
- Responsible party
- Sponsor
- Investigators
- Daniel Blero, Prof. MD., Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465383
- Sponsor's protocol ID
- OC08
- Acronym
- COLDiS
- Status last verified
- Sep 2022
- First submitted
- 6 Jul 2020
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Monocentric Study Comparing Digital Sedation Versus Intravenous Sedation Among Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT04465383
- Acronym / sponsor ID
- COLDiS / OC08
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment too complicated during pandemics. Phase 2 of recruitment completed and enough data available.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- OncomfortIndustry (pharma, biotech, devices)
- Collaborators
- Erasme University Hospital
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 10 Jul 2020 (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.
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.
Detailed description
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.
Participants will be recruited during the anesthesiology consultation conducted in preparation for colonoscopy. Those with indication for screening or diagnostic colonoscopy under conventional intravenous sedation (propofol) and willing to participate will provide their written informed consent and will be randomized (2:1) between two arms:
- Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if needed upon patient request
- Control arm: conventional intravenous sedation (propofol)
The study will be divided into three stages, with randomization (2:1) maintained throughout. In the first stage, accrual will be halted when about 45 patients have been randomized, at least 27 of whom being evaluable patients randomized to the experimental arm. A non-binding futility analysis is planned for the primary outcome. In the second stage, accrual will be halted when about 90 patients have been randomized. A non-binding futility analysis is planned for the primary outcome. If the milestones are met, accrual will be reopened to the second stage and the study will continue to the planned final accrual of 177 patients (118 to experimental and 59 to control arm, respectively). At the end of the recruitment of Stage 1 and 2, an analysis of the secondary outcomes will also be run. Results of these analysis could also impact the decision for pursuing to second/ third stage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Sedation | Experimental | Device: Aqua© 30 on Oncomfort SedakitTM, Drug: PropofolDigital Sedation with rescue intravenous sedation (propofol) if needed upon patient request |
| Intravenous sedation | Active comparator | Drug: PropofolControl arm with conventional Intravenous sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years or older
- Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Scheduled dilation
- Active Crohn Disease
- Low auditory acuity that precludes use of the device
- Low visual acuity that precludes use of the device
- Head or face wounds precluding use of the device
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 |
|---|---|---|
| Aqua© 30 on Oncomfort SedakitTMDigital Sedation session consists in a virtual reality software (Aqua© 30 Version 3.0, Oncomfort SA, Waver, Belgium) including a clinical hypnosis script.Patients in the intervention group will undergo a 30-minute Digital Sedation program through a VR headset and headphones. This medical device called Oncomfort SedakitTM has been created to reduce anxiety and pain during medical/ surgical interventions | Device | Digital Sedation |
| PropofolStandard sedation starting doses of 1 µg/ml to 6 µg/ml depending on patient's reaction and titrated incrementally by 0.5µg/ml. Doses are adapted according to the level of comfort and needs of the patient. | Drug | Digital Sedation, Intravenous sedation |
Primary outcome
To confirm the feasibility of using digital sedation in colonoscopy (stage 1)
Time frame: Day 1
cecal intubation rate, rate of rescue sedation
To demonstrate adequate performance of colonoscopy using digital sedation (stage 2)
Time frame: Day 1
cecal intubation rate, rate of rescue sedation
9 secondary outcomes
To compare patient experience in both arms
Time frame: Day 1 & Day 2 Follow-up call
To compare measures of colonoscopy performance in both arms
Time frame: Day 1
To assess the need for rescue sedation in the experimental arm
Time frame: Day 1
To compare use of sedation medication in both arms
Time frame: Day 1
To assess gastroenterologist and anesthesiologist satisfaction in both arms
Time frame: Day 1
To assess gastroenterologist and anesthesiologist stress in both arms
Time frame: Day 1
To compare physiologic measures in both arms
Time frame: Day 1
To assess difficulty or ease of the procedure in both arms
Time frame: Day 1
To compare the safety in both arms
Time frame: Screening, Day 1 & Day 2 Follow-up call
Results and safety
The study was stopped early (reason given: Recruitment too complicated during pandemics. Phase 2 of recruitment completed and enough data available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Daniel Blero, Prof. MD. principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqua© 30 on Oncomfort SedakitTM and Propofol in people with Colonoscopy, run by Oncomfort at 1 site in Belgium.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Recruitment too complicated during pandemics. Phase 2 of recruitment completed and enough data available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To confirm the feasibility of using digital sedation in colonoscopy (stage 1) (time frame: Day 1). The study lists 2 primary outcomes in all. 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 3 Oct 2022.