<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04465383</url>
  </required_header>
  <id_info>
    <org_study_id>OC08</org_study_id>
    <nct_id>NCT04465383</nct_id>
  </id_info>
  <brief_title>Digital Sedation: Virtual Reality Hypnosis During Colonoscopy</brief_title>
  <acronym>COLDiS</acronym>
  <official_title>A Prospective Randomized Controlled Monocentric Study Comparing Digital Sedation Versus Intravenous Sedation Among Patients Undergoing Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oncomfort</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oncomfort</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective Randomized Controlled Trial will evaluate efficacy, safety, and&#xD;
      pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation&#xD;
      using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care,&#xD;
      intravenous sedation with propofol. The Aqua© module is designed for sedation and management&#xD;
      of pain and anxiety related to medical and surgical procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective Randomized Controlled Trial will evaluate efficacy, safety, and&#xD;
      pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation&#xD;
      using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care,&#xD;
      intravenous sedation with propofol. The Aqua© module is designed for sedation and management&#xD;
      of pain and anxiety related to medical and surgical procedures.&#xD;
&#xD;
      Participants will be recruited during the anesthesiology consultation conducted in&#xD;
      preparation for colonoscopy. Those with indication for screening or diagnostic colonoscopy&#xD;
      under conventional intravenous sedation (propofol) and willing to participate will provide&#xD;
      their written informed consent and will be randomized (2:1) between two arms:&#xD;
&#xD;
        1. Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if&#xD;
           needed upon patient request&#xD;
&#xD;
        2. Control arm: conventional intravenous sedation (propofol)&#xD;
&#xD;
      The study will be divided into three stages, with randomization (2:1) maintained throughout.&#xD;
      In the first stage, accrual will be halted when about 45 patients have been randomized, at&#xD;
      least 27 of whom being evaluable patients randomized to the experimental arm. A non-binding&#xD;
      futility analysis is planned for the primary outcome. In the second stage, accrual will be&#xD;
      halted when about 90 patients have been randomized. A non-binding futility analysis is&#xD;
      planned for the primary outcome. If the milestones are met, accrual will be reopened to the&#xD;
      second stage and the study will continue to the planned final accrual of 177 patients (118 to&#xD;
      experimental and 59 to control arm, respectively). At the end of the recruitment of Stage 1&#xD;
      and 2, an analysis of the secondary outcomes will also be run. Results of these analysis&#xD;
      could also impact the decision for pursuing to second/ third stage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment too complicated during pandemics. Phase 2 of recruitment completed and enough data&#xD;
    available.&#xD;
  </why_stopped>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">December 21, 2021</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To confirm the feasibility of using digital sedation in colonoscopy (stage 1)</measure>
    <time_frame>Day 1</time_frame>
    <description>cecal intubation rate, rate of rescue sedation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To demonstrate adequate performance of colonoscopy using digital sedation (stage 2)</measure>
    <time_frame>Day 1</time_frame>
    <description>cecal intubation rate, rate of rescue sedation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare patient experience in both arms</measure>
    <time_frame>Day 1 &amp; Day 2 Follow-up call</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare measures of colonoscopy performance in both arms</measure>
    <time_frame>Day 1</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the need for rescue sedation in the experimental arm</measure>
    <time_frame>Day 1</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare use of sedation medication in both arms</measure>
    <time_frame>Day 1</time_frame>
    <description>Average (per patient) total doses of sedation medication per arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess gastroenterologist and anesthesiologist satisfaction in both arms</measure>
    <time_frame>Day 1</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess gastroenterologist and anesthesiologist stress in both arms</measure>
    <time_frame>Day 1</time_frame>
    <description>Measure of stress by Visual Analogue Scale (VAS 0 to 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare physiologic measures in both arms</measure>
    <time_frame>Day 1</time_frame>
    <description>Oxygen saturation (minimal observed during procedure), MBP (min/max.), Heart rate (min/max)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess difficulty or ease of the procedure in both arms</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of abdominal manipulations and patient mobilizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the safety in both arms</measure>
    <time_frame>Screening, Day 1 &amp; Day 2 Follow-up call</time_frame>
    <description>Frequency and type of AEs and SAEs, Frequency and severity of episodes of desaturation and of HR/ MBP changes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Digital Sedation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Digital Sedation with rescue intravenous sedation (propofol) if needed upon patient request</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous sedation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control arm with conventional Intravenous sedation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aqua© 30 on Oncomfort SedakitTM</intervention_name>
    <description>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</description>
    <arm_group_label>Digital Sedation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>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.</description>
    <arm_group_label>Digital Sedation</arm_group_label>
    <arm_group_label>Intravenous sedation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 18 years or older&#xD;
&#xD;
          -  Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)&#xD;
&#xD;
          -  Provision of written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Scheduled dilation&#xD;
&#xD;
          -  Active Crohn Disease&#xD;
&#xD;
          -  Low auditory acuity that precludes use of the device&#xD;
&#xD;
          -  Low visual acuity that precludes use of the device&#xD;
&#xD;
          -  Head or face wounds precluding use of the device&#xD;
&#xD;
          -  Schizophrenia&#xD;
&#xD;
          -  Dizziness&#xD;
&#xD;
          -  Water/sea phobia&#xD;
&#xD;
          -  Non-proficiency in French or Dutch (research language)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Blero, Prof. MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Erasme</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04465383
org study id: OC08
nct id: NCT04465383
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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:

        1. Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if
           needed upon patient request

        2. 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: To confirm the feasibility of using digital sedation in colonoscopy (stage 1)
time frame: Day 1
description: cecal intubation rate, rate of rescue sedation
measure: To demonstrate adequate performance of colonoscopy using digital sedation (stage 2)
time frame: Day 1
description: cecal intubation rate, rate of rescue sedation
measure: To compare patient experience in both arms
time frame: Day 1 & Day 2 Follow-up call
description: 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
measure: To compare measures of colonoscopy performance in both arms
time frame: Day 1
description: 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
measure: To assess the need for rescue sedation in the experimental arm
time frame: Day 1
description: 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
measure: To compare use of sedation medication in both arms
time frame: Day 1
description: Average (per patient) total doses of sedation medication per arm
measure: To assess gastroenterologist and anesthesiologist satisfaction in both arms
time frame: Day 1
description: 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)
measure: To assess gastroenterologist and anesthesiologist stress in both arms
time frame: Day 1
description: Measure of stress by Visual Analogue Scale (VAS 0 to 10)
measure: To compare physiologic measures in both arms
time frame: Day 1
description: Oxygen saturation (minimal observed during procedure), MBP (min/max.), Heart rate (min/max)
measure: To assess difficulty or ease of the procedure in both arms
time frame: Day 1
description: Number of abdominal manipulations and patient mobilizations
measure: To compare the safety in both arms
time frame: Screening, Day 1 & Day 2 Follow-up call
description: Frequency and type of AEs and SAEs, Frequency and severity of episodes of desaturation and of HR/ MBP changes
arm group label: Digital Sedation
arm group type: Experimental
description: Digital Sedation with rescue intravenous sedation (propofol) if needed upon patient request
arm group label: Intravenous sedation
arm group type: Active Comparator
description: Control arm with conventional Intravenous sedation
intervention type: Device
intervention name: Aqua© 30 on Oncomfort SedakitTM
description: 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
arm group label: Digital Sedation
intervention type: Drug
intervention name: Propofol
description: 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.
arm group label: Digital Sedation
arm group label: Intravenous sedation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Blero, Prof. MD.
role: Principal Investigator
affiliation: Hôpital Erasme
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Propofol
sharing ipd: No