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Diagnostic (BI, PPG) for Lymphedema

N/A

Waitlist Available

Led By Carlo M Contreras, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 hours

Awards & highlights

Study Summary

"This trial is testing new adhesive-based sensors that stick to the skin to detect cancer-related long-term arm swelling. Lymphedema is a condition that causes swelling in the arms and can be painful and

Who is the study for?

This trial is for healthy individuals and those with pre-existing lymphedema due to cancer therapy involving surgery or radiation. Participants should have arm swelling needing compression or a significant size difference between arms. Active cancer patients, except breast cancer ones on endocrine monotherapy, can't join.Check my eligibility

What is being tested?

The study tests new skin-adhesive sensors that detect early signs of lymphedema using photoplethysmography (PPG) and bioimpedance (BI). PPG measures blood volume changes in tissue, while BI assesses tissue response to electrical currents. The goal is to help patients monitor lymphedema at home.See study design

What are the potential side effects?

Since the interventions include non-invasive procedures like exercise, questionnaires, and sensor application for measurement purposes only, there are minimal expected side effects from participating in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Unique signature describing photoplethysmography and bioimpedance at rest and during activity

Secondary outcome measures

Likely classification for lymphedema

Patient reported outcomes

Tolerability of sensors

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (BI, PPG)Experimental Treatment4 Interventions

Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bioelectric Impedance Analysis

2012

Completed Phase 2

~120

Photoplethysmography

2021

Completed Phase 3

~480

Questionnaire Administration

2016

Completed Phase 3

~5140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,097 Total Patients Enrolled

1 Trials studying Lymphedema

100 Patients Enrolled for Lymphedema

Carlo M Contreras, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

3 Previous Clinical Trials

145 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 85 years of age being sought for participation in this research study?

"Individuals aged 18 to 90 are eligible for participation based on the inclusion criteria of this clinical study."

Answered by AI

What are the eligibility criteria for individuals who can participate in this medical research study?

"To meet the requirements for participation, individuals need to have lymphedema and fall between 18 and 90 years old. The study is currently open to approximately 70 eligible candidates."

Answered by AI

Is the current clinical trial open for enrollment?

"As per information available on clinicaltrials.gov, the ongoing trial is not currently seeking participants. The trial was first listed on April 1st, 2024 and last modified on March 5th, 2024. While this specific study is inactive in terms of recruitment, it's noteworthy that there are a substantial number of other trials actively seeking candidates - totaling at 2680 trials presently open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

Carlo Contreras 2024. "Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305884.

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