Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495528
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
Sponsor:
Butterfly Therapeutics
Organization:
Butterfly Therapeutics
Study Overview
Official Title:
Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPATPAC
Brief 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
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 andor anxiolytics andor MEOPA andor 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
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 andor anxiolytics andor MEOPA andor 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 andor anxiolytics andor MEOPA andor 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
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 andor anxiolytics andor MEOPA andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None