Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305884
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-05
Brief Title:
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema Project Limb Rescue Study
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Project Limb Rescue A Pilot Study Evaluating the Feasibility of Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema
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:
This clinical trial studies how well new adhesive-based sensors that stick to the skin transcutaneous work in detecting cancer-related long-term arm swelling lymphedema For many patients lymphedema s painful unsightly and weakening The early signs of lymphedema are hard to see and sometimes it is only diagnosed by hospital equipment at larger centers Treating lymphedema early is usually more successful than trying to treat in later stages The adhesive-based sensors used in this study work by using techniques called photoplethysmography PPG and bioimpedance BI PPG is an optical technique that can be used to detect blood volume changes in tissue BI evaluates how tissue responds to an externally applied electrical current This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema and develop a way for patients to check for lymphedema at home
Detailed Description:
PRIMARY OBJECTIVE
I Describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes participants with lymphedema in comparison to participants without lymphedema at rest
SECONDARY OBJECTIVES
I In participants with lymphedema describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes the affected arm in comparison to the unaffected arm
II Tolerability of the transcutaneous sensors during the participant data collection session
III Use a combination of photoplethysmography and bioimpedance to identify likely cut points for lymphedema in participants with lymphedema
OUTLINE
Participants undergo BI and wear watch-like sensors and undergo PPG at rest and while active pedaling an exercise bike on study
I Describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes participants with lymphedema in comparison to participants without lymphedema at rest
SECONDARY OBJECTIVES
I In participants with lymphedema describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes the affected arm in comparison to the unaffected arm
II Tolerability of the transcutaneous sensors during the participant data collection session
III Use a combination of photoplethysmography and bioimpedance to identify likely cut points for lymphedema in participants with lymphedema
OUTLINE
Participants undergo BI and wear watch-like sensors and undergo PPG at rest and while active pedaling an exercise bike on study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-03077 | REGISTRY | CTRP Clinical Trial Reporting Program | None |