CancerEPATPACNCT06495528
Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
A study testing Pain management with BLISS DTx in people with Cancer, run by Butterfly Therapeutics at 1 site in France.
Trial summary
Setting a Port-a Cath is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is placed in the upper part of the thorax, under the clavicle, and facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Pain management with BLISS DTx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2024to 12 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, aged ≥ 18 years
- Patient with a cancer diagnosis
- Patient with Port-A-Cath setting under ambulatory
- Patient affiliated to or beneficiary of a social security system
- French speaking patient having signed informed consent
Who cannot join
- Patient with previous Port-A-Cath setting
- Patient with pain perception disorder
- Patient with contraindication to the use of virtual reality (VR) and screens
- Pregnant woman
- Protected patient
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers, 49933
Jean PICQUET, MD, + 33 2 41 35 38 37, jean.picquet@chu-angers.fr
About this study
Setting a Port-a Cath is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is placed in the upper part of the thorax, under the clavicle, and facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.
Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics, hypnotics or inhalation of MEOPA.
Read more
Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.
This study is based on the hypothesis that Bliss DTx use would :
- Be clinically equivalent to a standard protocol (use of hypnotics and/or anxiolytics and/or MEOPA and/or hypnosis conversational) to manage pain during Port-a Cath setting under local anesthesia
- Reduce anxiety before setting a Port-a Cath
- Provide greater satisfaction with the treatment process from patient point of view
- Have organizational impacts, some of which could be economically valued
Read the detailed description
An implantable catheter port, also called Port-a Cath, is placed in the upper part of the thorax under the clavicle. Setting is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is set up to facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.
Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics as premedication, hypnotics before or during the Port-a Cath setting, inhalation of MEOPA (equimolar mixture of oxygen and nitrogen protoxide, medicinal anxiolytic and analgesic gas , colorless and slightly odorous, mainly used in a hospital environment).
Virtual reality technology allows a person to be immersed in a virtual environment using a device consisting of headset audio and 3D display system. This is a non-invasive device that has an effect on the anxiety and pain level of patients. Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx which was released in 2021 showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.
Bliss DTx is also used in everyday practice by many doctors, surgeons, anesthetists and nurses, who do not observe significant pain difference between Bliss DTx and chemical sedations during the acts, but note interesting differences from an organizational point of view between the different methods.
A new evolution of Bliss DTx offers features that allow to increase winnings throughout the course including installation of a Port-a Cath.
This study is therefore based on the hypothesis that Bliss DTx use would :
- Be clinically equivalent to a standard protocol (use of hypnotics and/or anxiolytics and/or MEOPA and/or hypnosis conversational) to manage pain during Port-a Cath setting under local anesthesia
- Reduce anxiety before setting a Port-a Cath
- Provide greater satisfaction with the treatment process from patient point of view
- Have organizational impacts, some of which could be economically valued, contributing to optimization of the entire course care for patients with Port-a Cath setting
- Conditions
- Cancer
- Being tested
- Pain management with BLISS DTx, Pain Management with site standard of care sedation protocol
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain management with BLISS DTxDevice
Bliss DTx is a Digital Therapeutics (DTx) which uses virtual reality augmented with sound and visual stimuli to reduce pain during Port-A-Cath setting
Pain Management with site standard of care sedation protocolOther
Sedation (morphine and/or hypnotics and/or anxiolytics and/or conversational hypnosis) reduces pain during Port-A-Cath setting
| Study group | Role | What they receive |
|---|---|---|
| BLISS Arm | Experimental | Port-A-Cath setting under local anesthesia combined with Bliss DTx use Receives: Device: Pain management with BLISS DTx |
| GOLD STANDARD Arm | Other | Port-A-Cath setting under local anesthesia combined with site standard of care sedation protocol Receives: Other: Pain Management with site standard of care sedation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Maximum pain level during Port-A-Cath setting will be assessed using Visual Analog Scale : from 0 (no pain) to 10 (intolerable)
Measured: 1 day
Patient anxiety
Patient anxiety before Port-A-Cath setting will be assessed with Hamilton score.
Score 10 to 13: mild depressive symptoms. Score 14 to 17: mild to moderate depressive symptoms. Score greater than 18: moderate to severe depressive
Measured: 1 day
Patient satisfaction
The overall experience score and patient satisfaction will be assessed using the e-Satis questionnaire in ambulatory surgery (MCO CA) at the end of the treatment course. This a specific french questionnaire without global final score. There are only questions with following rating : poor, weak, medium, good, excellent
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start12 Jun 2024
- Primary completion12 May 2025 (estimated)
- Study completion12 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butterfly Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495528
- Sponsor's protocol ID
- 2023-A02483-42
- Acronym
- EPATPAC
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
- ClinicalTrials.gov ID
- NCT06495528
- Acronym / sponsor ID
- EPATPAC / 2023-A02483-42
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Butterfly TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 12 May 2025 (estimated)
- Study completion
- 12 May 2025 (estimated)
- First posted
- 10 Jul 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.
Setting a Port-a Cath is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is placed in the upper part of the thorax, under the clavicle, and facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.
Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics, hypnotics or inhalation of MEOPA.
Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.
This study is based on the hypothesis that Bliss DTx use would :
- Be clinically equivalent to a standard protocol (use of hypnotics and/or anxiolytics and/or MEOPA and/or hypnosis conversational) to manage pain during Port-a Cath setting under local anesthesia
- Reduce anxiety before setting a Port-a Cath
- Provide greater satisfaction with the treatment process from patient point of view
- Have organizational impacts, some of which could be economically valued
Detailed description
An implantable catheter port, also called Port-a Cath, is placed in the upper part of the thorax under the clavicle. Setting is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is set up to facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.
Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics as premedication, hypnotics before or during the Port-a Cath setting, inhalation of MEOPA (equimolar mixture of oxygen and nitrogen protoxide, medicinal anxiolytic and analgesic gas , colorless and slightly odorous, mainly used in a hospital environment).
Virtual reality technology allows a person to be immersed in a virtual environment using a device consisting of headset audio and 3D display system. This is a non-invasive device that has an effect on the anxiety and pain level of patients. Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx which was released in 2021 showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.
Bliss DTx is also used in everyday practice by many doctors, surgeons, anesthetists and nurses, who do not observe significant pain difference between Bliss DTx and chemical sedations during the acts, but note interesting differences from an organizational point of view between the different methods.
A new evolution of Bliss DTx offers features that allow to increase winnings throughout the course including installation of a Port-a Cath.
This study is therefore based on the hypothesis that Bliss DTx use would :
- Be clinically equivalent to a standard protocol (use of hypnotics and/or anxiolytics and/or MEOPA and/or hypnosis conversational) to manage pain during Port-a Cath setting under local anesthesia
- Reduce anxiety before setting a Port-a Cath
- Provide greater satisfaction with the treatment process from patient point of view
- Have organizational impacts, some of which could be economically valued, contributing to optimization of the entire course care for patients with Port-a Cath setting
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLISS Arm | Experimental | Device: Pain management with BLISS DTxPort-A-Cath setting under local anesthesia combined with Bliss DTx use |
| GOLD STANDARD Arm | Other | Other: Pain Management with site standard of care sedation protocolPort-A-Cath setting under local anesthesia combined with site standard of care sedation protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female, aged ≥ 18 years
- Patient with a cancer diagnosis
- Patient with Port-A-Cath setting under ambulatory
- Patient affiliated to or beneficiary of a social security system
- French speaking patient having signed informed consent
Key exclusion criteria (5 listed)
- Patient with previous Port-A-Cath setting
- Patient with pain perception disorder
- Patient with contraindication to the use of virtual reality (VR) and screens
- Pregnant woman
- Protected patient
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 |
|---|---|---|
| Pain management with BLISS DTxBliss DTx is a Digital Therapeutics (DTx) which uses virtual reality augmented with sound and visual stimuli to reduce pain during Port-A-Cath setting | Device | BLISS Arm |
| Pain Management with site standard of care sedation protocolSedation (morphine and/or hypnotics and/or anxiolytics and/or conversational hypnosis) reduces pain during Port-A-Cath setting | Other | GOLD STANDARD Arm |
Primary outcome
Pain level
Time frame: 1 day
Maximum pain level during Port-A-Cath setting will be assessed using Visual Analog Scale : from 0 (no pain) to 10 (intolerable)
Patient anxiety
Time frame: 1 day
Patient anxiety before Port-A-Cath setting will be assessed with Hamilton score. Score 10 to 13: mild depressive symptoms. Score 14 to 17: mild to moderate depressive symptoms. Score greater than 18: moderate to severe depressive
Patient satisfaction
Time frame: 1 day
The overall experience score and patient satisfaction will be assessed using the e-Satis questionnaire in ambulatory surgery (MCO CA) at the end of the treatment course. This a specific french questionnaire without global final score. There are only questions with following rating : poor, weak, medium, good, excellent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain management with BLISS DTx in people with Cancer, run by Butterfly Therapeutics at 1 site in France.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katell Le Dû, MD (+33 2 28 25 56 87, dr.ledu@groupeconfluent.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 1 day). The study lists 3 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 10 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.