Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06495528

Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting

Led by Butterfly Therapeutics · Updated on 2024-07-10

318

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient, male or female, aged 218 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Angers

Angers, France, 49933

Actively Recruiting

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Research Team

K

Katell Le Dû, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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