Viewing Study NCT04897035



Ignite Creation Date: 2024-05-06 @ 4:10 PM
Last Modification Date: 2024-10-26 @ 2:05 PM
Study NCT ID: NCT04897035
Status: COMPLETED
Last Update Posted: 2022-12-01
First Post: 2021-05-12

Brief Title: A Non-randomized Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Sponsor: Koya Medical Inc
Organization: Koya Medical Inc

Study Overview

Official Title: A Non-randomized Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Status: COMPLETED
Status Verified Date: 2021-05
Last Known Status: None
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: TIBER
Brief Summary: A Non-randomized Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Detailed Description: A Non-randomized Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None