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

NCT06495528 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2024-07-10

No results posted yet for this study

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 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

Interventions

DEVICE

Pain management with BLISS DTx

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

OTHER

Pain Management with site standard of care sedation protocol

Sedation (morphine and/or hypnotics and/or anxiolytics and/or conversational hypnosis) reduces pain during Port-A-Cath setting

Sponsors & Collaborators

  • Butterfly Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2025-05-12
Completion
2025-05-12

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06495528 on ClinicalTrials.gov