Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-14 @ 3:16 AM
Study NCT ID:
NCT05176834
Status:
UNKNOWN
Last Update Posted:
2022-02-24
First Post:
2021-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies
Sponsor:
Erika Carmel ltd
Organization:
Study Overview
Official Title:
Self-applied Photobiomodulation Therapy With a Home-use Device for the Prevention and/or Acceleration of Healing of Radiation-induced Oral Mucositis in Patients With Head and Neck Malignancies - A Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
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:
PBM&OM-01
Brief Summary:
Patients with head and neck malignancy that are treated with Radiation Therapy \[RT\] are expected to develop Oral Mucositis (OM) in 60% of cases. Mucositis is a side effect of radiation and / or chemotherapy that causes severe pain and inability to eat and drink and a decrease in quality of life. In addition it may impair the treatment protocol and treatment outcomes.
Photobiomodulation is a non-ionizing optical radiation in the near or near-infrared range used for acceleration of wound healing and pain reduction. Photobiomodulation therapy for the reduction of mucositis is included in the International Guidelines of the MASCC / ISOO Association and the British NICE. To date the treatment has been performed by members of professional medical staff in hospitals or clinics.
The study device is home-used photobiomodulation device approved for indications of pain reduction and acceleration of wound healing. The device has shown efficacy in treating mucositis around dental implants in a clinical trial and after oncological treatments in a limited number of cases as reported in the scientific literature.
Photobiomodulation is a non-ionizing optical radiation in the near or near-infrared range used for acceleration of wound healing and pain reduction. Photobiomodulation therapy for the reduction of mucositis is included in the International Guidelines of the MASCC / ISOO Association and the British NICE. To date the treatment has been performed by members of professional medical staff in hospitals or clinics.
The study device is home-used photobiomodulation device approved for indications of pain reduction and acceleration of wound healing. The device has shown efficacy in treating mucositis around dental implants in a clinical trial and after oncological treatments in a limited number of cases as reported in the scientific literature.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: