An interventional study of Aqua© 30 on Oncomfort SedakitTM and Propofol in Colonoscopy, sponsored by Oncomfort. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-03.
Sponsored by Oncomfort · Not applicable, Interventional, and Supportive care
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.
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:
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.
Oncomfort is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Digital Sedation with rescue intravenous sedation (propofol) if needed upon patient request
Device: Aqua© 30 on Oncomfort SedakitTM · Drug: Propofol
Control arm with conventional Intravenous sedation
Drug: Propofol
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
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.
To confirm the feasibility of using digital sedation in colonoscopy (stage 1)
cecal intubation rate, rate of rescue sedation
Time frame: Day 1
To demonstrate adequate performance of colonoscopy using digital sedation (stage 2)
cecal intubation rate, rate of rescue sedation
Time frame: Day 1
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
Time frame: 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
Time frame: 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
Time frame: Day 1
To compare use of sedation medication in both arms
Average (per patient) total doses of sedation medication per arm
Time frame: 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)
Time frame: Day 1
To assess gastroenterologist and anesthesiologist stress in both arms
Measure of stress by Visual Analogue Scale (VAS 0 to 10)
Time frame: Day 1
To compare physiologic measures in both arms
Oxygen saturation (minimal observed during procedure), MBP (min/max.), Heart rate (min/max)
Time frame: Day 1
To assess difficulty or ease of the procedure in both arms
Number of abdominal manipulations and patient mobilizations
Time frame: 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
Time frame: Screening, Day 1 & Day 2 Follow-up call
Plan to share: No
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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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