Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134167
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-10-18
Brief Title:
A Study to Evaluate the Safety and Effectiveness Transdermal Compress Device in Participants With Transfemoral Amputations
Sponsor:
Balmoral Medical company
Organization:
Balmoral Medical company
Study Overview
Official Title:
A Prospective Multicenter Single-Arm Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants With Transfemoral Amputations
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations
Detailed Description:
This study is a prospective multicenter single-arm open-label study in skeletally mature participants with transfemoral limb loss unilateral or bilateral without bone or vascular disease who have or are anticipated to have rehabilitation problems with or cannot use a conventional socket prosthesis
Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1
Participant progression including clinical assessments and prosthetic use will follow the study rehabilitation protocol
Events of special interest include superficial and deep infections at the implant site failures and secondary surgical interventions participants will be followed for all soft tissue interface issues
Participants will be assessed for effectiveness and safety endpoints at baseline and at Months 6 12 18 and 24 and annually through 5 years post-implantation
Adverse events and adverse device effects will be collected and reported starting at the time of surgical implantation
Study participants will also be included in the Osseointegration Quality Registry in parallel to this study to allow for long-term follow-up post-study
Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1
Participant progression including clinical assessments and prosthetic use will follow the study rehabilitation protocol
Events of special interest include superficial and deep infections at the implant site failures and secondary surgical interventions participants will be followed for all soft tissue interface issues
Participants will be assessed for effectiveness and safety endpoints at baseline and at Months 6 12 18 and 24 and annually through 5 years post-implantation
Adverse events and adverse device effects will be collected and reported starting at the time of surgical implantation
Study participants will also be included in the Osseointegration Quality Registry in parallel to this study to allow for long-term follow-up post-study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None