Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)
NCT06222788 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-06-27
Summary
The goal of this clinical trial is to test the safety of the use of non-thermal plasma (NTP, an ionized gas) on the tumor bed after the removal of the tumor in breast cancer patients. The main questions it aims to answer are:
* To determine the safe and tolerable dose of NTP in patients with breast cancer;
* To assess the safety and tolerability of NTP;
* To assess the cosmetic effects of NTP treatment in patients with breast cancer. Participants will receive one treatment of the tumor bed after the removal of their breast tumor.
Conditions
Interventions
- DEVICE
-
Convertible Plasma Jet
NTP will be applied to the patients using the Convertible Plasma Jet (CPJ, NexPlasmaGen Inc.)
Sponsors & Collaborators
-
Ozmosis Research Inc.
collaborator INDUSTRY -
Ministère de l'Économie, de l'Innovation et de l'Énergie, Québec, Canada
collaborator UNKNOWN -
Quebec Breast Cancer Foundation
collaborator OTHER -
Centre hospitalier de l'Université de Montréal (CHUM)
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-30
- Primary Completion
- 2026-01-31
- Completion
- 2026-01-31
Countries
- Canada
Study Locations
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