Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01831024
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2013-04-03
Brief Title:
Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia
Sponsor:
Target Health Inc
Organization:
Target Health Inc
Study Overview
Official Title:
Clinical Performance Efficacy and Safety of the DigniCap System a Scalp Hypothermia System in Preventing Chemotherapy Induced Alopecia in Patients With Early Stage Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy regimens The scalp cold cap will be applied at each chemotherapy cycle Hair loss will be evaluated by patient self assessment of 5 standardized photographs taken prior to each chemotherapy cycle A concurrent control group not using a cold cap will also be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None